PMA · Approved

Recalled · Class II · 2016

UV Absorbing Silicone Posterior Chamber Intraocular Lenses

P880081PMAApproved Oct 31, 1989358-day reviewClass III21 CFR 886.3600Recalls 21

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

Johnson & Johnson Surgical Vision, Inc. · HQL Intraocular Lens

Approved on Oct 31, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 358-day review. It has been recalled 21 times.

Decided: Oct 31, 1989
Review: 358 days
Class: Class III
Product code: HQL
Recalls: 21

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

P880081 has 39 supplements since 1990: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

1990high 5 (1990) · low 0 (1993)2024

View FIG. 1 as a table

Year	Supplements approved
1990	5
1991	3
1992	2
1994	2
1995	2
1996	1
1997	3
1999	1
2000	1
2002	1
2003	1
2005	2
2006	1
2007	3
2008	1
2012	1
2013	1
2015	1
2016	1
2018	1
2019	2
2021	1
2022	1
2024	1

FIG. 1 — Supplements to P880081, 1990–2024Source: 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 HQL? 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

Get a 510(k) Report

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
Aug 26, 2016	Class II	Z-2864-2016	Process control	Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
May 13, 2014	Class II	Z-2273-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2272-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2287-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2283-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2282-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2278-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2280-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2271-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2274-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2277-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2281-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2279-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2276-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2275-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2285-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2286-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
May 13, 2014	Class II	Z-2284-2014	Error in labeling	Units may be labeled with the incorrect diopter power.
Jan 28, 2014	Class II	Z-1123-2014	Nonconforming Material/Component	Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Oct 31, 2006	Not classified	Z-0267-2007	Other	These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
Jul 2, 2003	Not classified	Z-1036-03	Other	Post operative complaints of cloudiness in the intraocular lenses.

The 5 latest of 21 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All HQL devices

HQL Intraocular Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQL

42in 2025

2007high 57 (2019) · low 18 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQL

Too few HQL 510(k)s in any year since 2007 to give a median.

Recalls per year · HQL

3in 2018

2007high 9 (2011) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HQL

3,792in 2025

2007high 4,673 (2015) · low 1,868 (2009)2025

MAUDE reports naming product code HQL, 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	51	—	0	3,640
2008	48	—	1	3,137
2009	33	—	2	1,868
2010	44	—	0	2,172
2011	32	—	9	2,672
2012	38	—	1	2,802
2013	30	—	1	2,555
2014	18	—	0	2,649
2015	27	—	2 (1)	4,673
2016	48	—	0	2,214
2017	41	—	0	2,386
2018	39	—	3	2,501
2019	57	—	0	3,086
2020	49	—	0	1,981
2021	53	—	0	2,925
2022	34	—	0	3,290
2023	29	—	0	3,906
2024	35	—	0	3,110
2025	42	—	0	3,792
2026	38	—	0	—

https://510kreport.com/device/P880081 · printed Nov 6, 2026

Cite this page

510(k) Report. “P880081: UV Absorbing Silicone Posterior Chamber Intraocular Lenses.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P880081

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Record history

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