WHITESTAR SIGNATURE OPO70Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · NEXT GENERATION PHACO A-PACK · Class 2
All models of WHITESTAR SIGNATURE (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474533479), received between Mar 28, 2018 and Mar 15, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Hole In Material” (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 18, 2026.
Most reported problems
Device problems
- Hole In Material1
- Infusion or Flow Problem1
- Leak/Splash1
Patient problems
- Capsular Bag Tear1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2021Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT AFTER A NORMAL PRIME AND TUNE THE OPERATION STARTED. DURING THE LENS REMOVING PROCESS (QUADRANT) THE IRRIGATION WAS DIMINISHING AND SUDDENLY THERE WAS A COMPLICATION. A TEAR IN THE CAPSULE OF THE LENS. THEREFORE A 3 PIECE IOL (INTRA OCULAR LENS) HAD TO BE IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 11485784 ↗InjuryMar 28, 2018Hole In Material; Leak/Splash; Hole In Material; Leak/Splash
AFTER A CATARACT PROCEDURE, A SCRUB NURSE AT AN EYE CLINIC NOTICED THE TUBING PACK WAS LEAKING. THE SURGERY CENTER OBSERVED A SMALL HOLE IN ONE OF THE TUBING LINES. AS A PRECAUTIONARY MEASURE, ANTIBIOTICS WAS ADMINISTERED TO THE PATIENT DUE TO A POSSIBILITY OF POTENTIAL CONTAMINATION FROM THE ENDOSOL-BALANCE SALT SOLUTION THAT MAY HAVE REGURGITATED/IRRIGATED BACK INTO THE EYE. A PRESCRIPTION WAS ORDERED FOR 3 DAYS POST OP. AT A 1-DAY POST OP EXAM, THE PATIENT OUTCOME WAS NORMAL AND CONTROLLED.
Patient problems: No Code Available
MAUDE report 7376501 ↗
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- 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
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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