Boston Equalens II oprifocon ARecalls & reported problems

Bausch & Lomb Incorporated · Rigid Gas Permeable Contact Lens · Class 3

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00785811435639), received between Aug 26, 2025 and Aug 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 FDA recall records name this device's identifier.

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.

Recalls naming this device

Jun 10, 2025Class IICompleted
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Z-2191-2025 · Root cause: Process control · Recall details · FDA record ↗
Jun 10, 2025Class IICompleted
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Z-2190-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Device Handling Problem1

Patient problems

Corneal Abrasion1

Recent adverse event reports

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

InjuryAug 26, 2025Device Handling Problem; Device Handling Problem
PATIENT STATES THAT UPON REMOVAL OF THE DEVICE HER EYE SWELLED AND BECAME RED. PT. REPORTED PAIN AND BLURRED VISION.
Patient problems: Corneal Abrasion
MAUDE report 22896332 ↗

Device details

UDI-DI	`00785811435639`
Brand	Boston Equalens II
Model	oprifocon A
Catalog no.	Boston Equalens II
Company	Bausch & Lomb Incorporated
Product code	MWL · Lens,Contact(Rigid Gas Permeable)-Extended Wear
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 17, 2026

Device type (GMDN): Rigid-gas-permeable corrective contact lens, extended-wear

A rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed for continuous overnight wear for up to 7, 15, or 30 consecutive nights. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. The lens may last for years and is a reusable device.

Other Lens,Contact(Rigid Gas Permeable)-Extended Wear devices

MeniconZ (tisilfocon A) Blue
Menicon CO.,Ltd. · Lens,Contact(Rigid Gas Permeable)-Extended Wear
3 reports

All Lens,Contact(Rigid Gas Permeable)-Extended Wear 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 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page