PMA · Approved

Recalled · Class II · 2025

Biofinity (Comfilcon a)

P080011PMAApproved Nov 19, 2008226-day reviewClass III21 CFR 886.5925Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

CooperVision, Inc. · LPM Lenses, Soft Contact, Extended Wear

Approved on Nov 19, 2008 through premarket approval, which rests on the device’s own clinical evidence after a 226-day review. It has been recalled 4 times.

Decided: Nov 19, 2008
Review: 226 days
Class: Class III
Product code: LPM
Recalls: 4

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P080011 has 201 supplements since 2009: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2009high 18 (2018) · low 1 (2009)2026

View FIG. 1 as a table

Year	Supplements approved
2009	1
2010	2
2011	3
2012	13
2013	8
2014	4
2015	9
2016	10
2017	14
2018	18
2019	16
2020	17
2021	16
2022	18
2023	6
2024	18
2025	17
2026	11

FIG. 1 — Supplements to P080011, 2009–2026Source: FDA PMA database

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

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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 16, 2025	Class II	Z-2165-2025	Use error	Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Jun 16, 2025	Class II	Z-2166-2025	Use error	Lens blisters may have an incomplete or leaking seal which may render them unsterile.
Jan 26, 2023	Class II	Z-1197-2023	Employee error	Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Jan 26, 2023	Class II	Z-1198-2023	Employee error	Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

No ancestor or descendant has a Class I recall.

How does its category compare?

All LPM devices

LPM Lenses, Soft Contact, Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LPM

31in 2025

2007high 79 (2017) · low 4 (2007)2026

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

2007high 3 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPM

111in 2025

2007high 220 (2016) · low 42 (2008)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/P080011 · printed Nov 6, 2026

Cite this page

510(k) Report. “P080011: Biofinity (Comfilcon a).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P080011

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026