LAMINAR OPOHF20LRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · SLEEVE & TEST CHAMBER, 20GA HIGH FLOW · Class 2
All models of LAMINAR (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474535312), received between Apr 28, 2022 and Dec 28, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 reports).
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
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2023Contamination; Contamination
IT WAS REPORTED THAT IN A NEW SLEEVE USED, A ROUND FOREIGN OBJECT CAME OUT OF THE SLEEVE. THE FOREIGN MATTER WAS REPORTED TO BE PURPLE, SHAPED THE SIZE OF THE GAP IN THE PHACO TIP. WHEN IT WAS FOUND IN THE EYE, IT WAS REMOVED DURING IRRIGATION AND ASPIRATION (I/A), AND WHEN THE PHYSICIAN TRIED TO REMOVE, IT DISAPPEARED. THE PHYSICIAN COULD NOT FIND THE FOREIGN MATTER IN THE PATIENT'S EYE WHEN THEY CHECKED AFTER SURGERY. THERE WAS NO PATIENT INJURY TO DATE. THERE WAS A 20 MINUTE DELAY TO PROCEDURE (NOT SIGNIFICANT). NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18415010 ↗MalfunctionApr 28, 2022Contamination; Contamination
IT WAS REPORTED THAT A PIECE OF OPAQUE FOREIGN MATTER ENTERED PATIENT'S EYE DURING IRRIGATION/ASPIRATION PROCEDURE. THE FOREIGN MATTER WAS IMMEDIATELY REMOVED WITH FORCEPS BY THE SURGEON. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE MINUTE DELAY. THE FOREIGN MATTER WAS COLLECTED. IT WAS ALLEGED THAT THE FOREIGN MATER LOOKED LIKE A FRAGMENT ORIGINATED FROM PHACO TIP SLEEVE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14232386 ↗
Other Unit, phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page