LAMINAR OPOR0020LRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · LAMINAR FLOW PHACO TIP 0 DEG INVSLV 20G · 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 05050474521124), received between Sep 10, 2019 and Sep 10, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Prime” (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
- Failure to Prime1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2019Failure to Prime; Obstruction of Flow; Failure to Prime; Obstruction of Flow
DURING A CATARACT PROCEDURE, THE PHACO TIP WAS CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE PHACO PROCEDURE, A 501-PRIMING ERROR DISPLAYED. THE SURGERY CENTER REPLACED THE TUBING PACK; HOWEVER, THE ISSUE WAS NOT RESOLVED. IT WAS NOTED THE INSIDE OF A NEW TIP WAS CLOGGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP. NO PATIENT INJURY IS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8980065 ↗
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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