PMA · Approved
Recalled · Class II · 2014H55 Hydrophilic Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Cooper Companies · LPM Lenses, Soft Contact, Extended Wear
Approved on Sep 19, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 169-day review. 18 later devices descend from it. It has been recalled once.
- Decided
- Sep 19, 1989
- Review
- 169 days
- Class
- Class III
- Product code
- LPM
- Recalls
- 1
18 later devices descend from it, 6 citing it directly.
- This deviceP890023 H55 Hydrophilic Contact LensThe Cooper Companies · 1989
- Descendant · cites it directly · 15 of its ownK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
- Descendant · cites it directly · 13 of its ownK982947 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 1999
- Descendant · cites it directly · 11 of its ownK020193 Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft…Cl Mcintosh · 2002
- Descendant · cites it directly · 10 of its ownK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001
- Descendant · cites it directly · 9 of its ownK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K984046Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999 · cites it directly15descendants
- K982947Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 1999 · cites it directly13descendants
- K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensCl Mcintosh · 2002 · cites it directly11descendants
- K012425Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001 · cites it directly10descendants
- K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P890023 | H55 Hydrophilic Contact Lens | The Cooper Companies | 1989 | — |
| +1 | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| +1 | K982947 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| +1 | K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic)… | Cl Mcintosh | 2002 | — |
| +1 | K012425 | Biomedics UV Multifocal | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| +1 | K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | 1999 | 15 |
| K982947 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens | 1999 | 13 |
| K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens | 2002 | 11 |
| K012425 | Biomedics UV Multifocal | 2001 | 10 |
| K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | 2010 | 9 |
| K992264 | Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact Lens | 1999 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2014 | Class II | Z-0529-2015 | Process control | Portions of the lots may contain units with an incorrect lens axis condition. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984046 (Ocular Sciences Puerto Rico, Inc., 1999) has gone furthest, with 15 descendants of its own.
How does its category compare?
All LPM devicesLPM Lenses, Soft Contact, Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPM
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPM
Too few LPM 510(k)s in any year since 2007 to give a median.
Recalls per year · LPM
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPM
111in 2025
MAUDE reports naming product code LPM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | — | 1 | 68 |
| 2008 | 15 | — | 0 | 42 |
| 2009 | 12 | — | 0 | 56 |
| 2010 | 30 | — | 3 | 108 |
| 2011 | 51 | — | 0 | 155 |
| 2012 | 49 | — | 0 | 181 |
| 2013 | 31 | — | 0 | 172 |
| 2014 | 26 | — | 3 | 111 |
| 2015 | 35 | — | 0 | 143 |
| 2016 | 43 | — | 0 | 220 |
| 2017 | 79 | — | 1 | 215 |
| 2018 | 59 | — | 1 | 195 |
| 2019 | 55 | — | 0 | 189 |
| 2020 | 45 | — | 0 | 107 |
| 2021 | 28 | — | 0 | 103 |
| 2022 | 40 | — | 0 | 82 |
| 2023 | 15 | — | 0 | 118 |
| 2024 | 31 | — | 0 | 163 |
| 2025 | 31 | — | 0 | 111 |
| 2026 | 23 | — | 0 | — |
https://510kreport.com/device/P890023 · printed Nov 6, 2026
Cite this page
510(k) Report. “P890023: H55 Hydrophilic Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P890023
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026