LAMINAR OPOF3020RRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · LMNR FLW PHACO FLRD TIP 30D 20G SL REUSE · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474573529), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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 16, 2026.
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2018Obstruction of Flow; Obstruction of Flow
DURING A CATARACT PROCEDURE, THE TIP BECAME OCCLUDED/CLOGGED USING A REUSABLE OPOF3020R- LAMINAR FLOW PHACO TIP. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THERE WAS A CLOGGED TIP DURING THE PROCEDURE, HENCE THE PROCEDURE WAS ABORTED AND NOT COMPLETED. THE SURGERY CENTER REPORTED 501 ERROR HAS BEEN OCCURRING FREQUENTLY AND IT IS UNKNOWN IF THE 501-ERROR OCCURRED DURING THE PROCEDURE. ALTHOUGH, THERE WAS AN ATTEMPT TO RESTART THE PHACOEMULSIFICATION UNIT, REPLACE THE PHACO HANDPIECE, AND REPLACE THE TUBING PACK, THE OCCLUSION WAS STILL PRESENT. THE PATIENT WAS SENT HOME. NO ADDITIONAL INFORMATION WILL BE PROVIDED BY THE SURGERY CENTER. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS FOR THE PHACO TIP. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOFRAGMENTATION UNIT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8086762 ↗
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.
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