LAMINAR OPOS21LDRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SLEEVE & TEST CHAMBER, 21GA (DISP) · Class 2
All models of LAMINAR (13)
Data updated Oct 16, 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 05050474547070), received between Dec 10, 2025 and Dec 10, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON NOVEMBER 17, 2025 A SALES REP WAS PRESENT IN THE OPERATING ROOM AND INDICATED THAT THE SURGEON COULD NOT DETERMINE WHEN THE CAPSULE BAG RUPTURE OCCURRED; WHETHER DURING POLISHING OR DURING IRRIGATION/ASPIRATION. THE ISSUE WAS FIRST RECOGNIZED WHEN THE SURGEON SAW VITREOUS DURING IMPLANTATION OF A DCB00 LENS. THE SURGEON SAW THE LENS DROP TO THE BOTTOM OF THE EYE AND HAD TO FISH THE LENS OUT. A VITRECTOMY AND SUTURE WAS NECESSARY AND THE PATIENT WAS SENT TO ANOTHER SITE TO REPLACE THE INTRAOCULAR LENS (IOL). THE EVENT CAUSED AN APPROXIMATELY 20 MINUTE DELAY IN THE PROCEDURE. THE AFFECTED EYE WAS THE LEFT EYE. THE PATIENT¿S CONDITION AND RECOVERY STATUS ARE CURRENTLY UNKNOWN. SALES REP NOTED THAT THE SURGEON IS RECENTLY GRADUATED AND BELIEVES THE EVENT WAS NOT RELATED TO THE PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NOTE: THIS REPORT IS FOR THE SLEEVE. A SEPARATE REPORT WILL FILED AGAINST THE I/A HANDPIECE AND IOL.
Patient problems: Capsular Bag Tear
MAUDE report 23772934 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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