Crystalens® AO IOL AO1UV (REF AO1UV-2600)Recalls & reported problems

Bausch & Lomb Incorporated · Crystalens AO accommodating posterior chamber intraocular lens +26.00D · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770523778), received between Jul 25, 2024 and Jul 25, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Dislodged or Dislocated1

Patient problems

Blurred Vision1
Capsular Contracture1
Posterior Capsule Opacification1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJul 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS INTO THE LEFT EYE, CAPSULAR FIBROSIS WAS OBSERVED. FIVE WEEKS AFTER THE ONSET OF CAPSULAR FIBROSIS, ASYMMETRIC LENS VAULTING WAS OBSERVED, BUT NOT TREATED. IT WAS ALSO REPORTED THAT THE PATIENT HAD DEVELOPED PROGRESSIVELY INCREASING ASTIGMATISM, UP TO 4 DIOPTERS BY 2 MONTHS POST-OP, SECONDARY TO ASYMMETRIC LENS VAULTING. APPROXIMATELY TWO AND A HALF MONTHS AFTER IMPLANTATION OF THE INITIAL IOL, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL DUE TO UNRESOLVED Z-SYNDROME. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS CAPSULAR FIBROSIS.
Patient problems: Blurred Vision; Capsular Contracture; Posterior Capsule Opacification
MAUDE report 19831356 ↗

Device details

UDI-DI	`10757770523778`
Brand	Crystalens® AO IOL
Model	AO1UV
Catalog no.	AO1UV-2600
Company	Bausch & Lomb Incorporated
Product code	NAA · Lens,Intraocular,Accommodative
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 27, 2026

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Other Lens,Intraocular,Accommodative devices

Crystalens® AO IOL AO1UV
Bausch & Lomb Incorporated · Lens,Intraocular,Accommodative
1 report
Crystalens® AO IOL AO1UV
Bausch & Lomb Incorporated · Lens,Intraocular,Accommodative
1 report

All Lens,Intraocular,Accommodative devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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