LAMINAR OPOR3020LRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · LAMINAR FLOW PHACO TIP 30 DEG INFSLV 20G · Class 2
All models of LAMINAR (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474500365), received between Aug 3, 2026 and Sep 25, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Contamination” (4 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
- Contamination4
Patient problems
- Eye Injury2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Contamination
Patient problems: Eye Injury
MAUDE report 50903485 ↗MalfunctionSep 25, 2026Contamination
Patient problems: Eye Injury
MAUDE report 50903465 ↗InjuryAug 11, 2026Contamination
It was reported that metal particles were found in the patient's eye during a medical examination following surgery. Through follow-up, we learned, that an anterior chamber lavage was performed on (b)(6) 2026. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210968 ↗MalfunctionAug 3, 2026Contamination
It was reported that, while using the device during the procedure, metal particles were found on the patient's anterior capsule during the groove removal. The particles were removed and the procedure was successfully completed. There was no patient injury and no further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123607 ↗
Other Unit, phacofragmentation devices
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- 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.
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