SOLO OPOIA20STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474521070), received between Dec 12, 2017 and Dec 27, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A CASE OF SUDDEN POSTERIOR VESICLE DAMAGE WHICH OCCURRED DURING IRRIGATION/ASPIRATION (IA) STEP FOR REMOVAL OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD) ON THE PATIENT'S RIGHT EYE. THE DOCTOR THINKS THERE IS A POSSIBILITY THAT THERE IS A PROBLEM WITH THE SUCTION OF IA DUE TO THE IA TIP. THE PHYSICIAN HAS BEEN USING SIGPRO FOR MORE THAN THREE YEARS, BUT THIS IS THE FIRST TIME TO HAVE THESE ISSUES. THROUGH FOLLOW-UP WE LEARNED, THAT AN ISTENT WAS USED AND POSTERIOR CAPSULE DAMAGE DURING OVD REMOVAL AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. THE IOL IMPLANTED WAS A DFW375 SERIAL NUMBER: (B)(6) DUE TO PATIENT INJURY THIS LENS WAS EXPLANTED, AND THE FOLLOWING LENS WAS IMPLANTED: AR40E 21.5D SERIAL NUMBER: (B)(6). DIAMOX WAS PRESCRIBED DUE TO INCREASED INTRAOCULAR PRESSURE. A VITRECTOMY WAS PERFORMED AND THE INCISION TO THE EYE WAS ENLARGED, REQUIRING SUTURES. THE OPERATION ON THE PATIENT'S LEFT EYE WAS POSTPONED. NO OTHER COMPLICATIONS WERE REPORTED AND HEALON NA 0.85 WAS USED FOR THESE CASE WITHOUT ISSUES RELATED TO IT. NO FURTHER DETAILS WERE PROVIDED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER JNJ DEVICE INVOLVED FOR THIS PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Intraocular Pressure Increased

  MAUDE report 18400905 ↗
• InjuryAug 24, 2021Break; Sharp Edges; Break; Sharp Edges

  IT WAS REPORTED THAT POSTERIOR CAPSULE RAPTURE OCCURRED WHILE SURGEON WAS POLISHING WITH THE IRRIGATION/ASPIRATION HANDPIECE DURING PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALLEGED THAT THE HANDPIECE TIP MIGHT HAVE HAD BURRS.

  Patient problems: Capsular Bag Tear

  MAUDE report 12362660 ↗
• InjuryAug 24, 2021Break; Sharp Edges; Break; Sharp Edges

  IT WAS REPORTED THAT POSTERIOR CAPSULE RAPTURE OCCURRED WHILE SURGEON WAS POLISHING WITH THE IRRIGATION/ASPIRATION HANDPIECE DURING PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALLEGED THAT THE HANDPIECE TIP MIGHT HAVE HAD BURRS.

  Patient problems: Capsular Bag Tear

  MAUDE report 12362463 ↗
• InjuryAug 24, 2021Break; Sharp Edges; Break; Sharp Edges

  IT WAS REPORTED THAT POSTERIOR CAPSULE RAPTURE OCCURRED WHILE SURGEON WAS POLISHING WITH THE IRRIGATION/ASPIRATION HANDPIECE DURING PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALLEGED THAT THE HANDPIECE TIP MIGHT HAVE HAD BURRS.

  Patient problems: Capsular Bag Tear

  MAUDE report 12362405 ↗
• InjuryAug 24, 2021Break; Sharp Edges; Break; Sharp Edges

  IT WAS REPORTED THAT POSTERIOR CAPSULE RAPTURE OCCURRED WHILE SURGEON WAS POLISHING WITH THE IRRIGATION/ASPIRATION HANDPIECE DURING PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALLEGED THAT THE HANDPIECE TIP MIGHT HAVE HAD BURRS.

  Patient problems: Capsular Bag Tear

  MAUDE report 12362362 ↗
• InjuryOct 5, 2018Material Erosion; Flaked; Restricted Flow rate; Material Erosion; Flaked; Restricted Flow rate

  DURING A CATARACT PROCEDURE, A BROKEN POSTERIOR CAPSULE OCCURRED ON THE OPERATIVE EYE RESULTING IN A VITRECTOMY PROCEDURE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE IRRIGATION AND ASPIRATION PORTION, THERE WAS RESISTANCE THAT WAS CAUGHT AT THE PHACO TIP. IT WAS OBSERVED THAT THE GOLD COLOR SURFACE OF THE TIP SEEMED TO BE STRIPPING AWAY. THE BROKEN CAPSULE RESULTED IN A VITRECTOMY PROCEDURE AND THE ANTERIOR VITREOUS ZONE WAS RESECTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 4 OF 4 REPORTS.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7939688 ↗
• InjuryOct 5, 2018Material Erosion; Flaked; Restricted Flow rate; Material Erosion; Flaked; Restricted Flow rate

  DURING A CATARACT PROCEDURE, A BROKEN POSTERIOR CAPSULE OCCURRED ON THE OPERATIVE EYE RESULTING IN A VITRECTOMY PROCEDURE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE IRRIGATION AND ASPIRATION PORTION, THERE WAS RESISTANCE THAT WAS CAUGHT AT THE PHACO TIP. IT WAS OBSERVED THAT THE GOLD COLOR SURFACE OF THE TIP SEEMED TO BE STRIPPING AWAY. THE BROKEN CAPSULE RESULTED IN A VITRECTOMY PROCEDURE AND THE ANTERIOR VITREOUS ZONE WAS RESECTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 3 OF 4 REPORTS.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7939680 ↗
• InjuryOct 5, 2018Material Erosion; Flaked; Restricted Flow rate; Material Erosion; Flaked; Restricted Flow rate

  DURING A CATARACT PROCEDURE, A BROKEN POSTERIOR CAPSULE OCCURRED ON THE OPERATIVE EYE RESULTING IN A VITRECTOMY PROCEDURE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE IRRIGATION AND ASPIRATION PORTION, THERE WAS RESISTANCE THAT WAS CAUGHT AT THE PHACO TIP. IT WAS OBSERVED THAT THE GOLD COLOR SURFACE OF THE TIP SEEMED TO BE STRIPPING AWAY. THE BROKEN CAPSULE RESULTED IN A VITRECTOMY PROCEDURE AND THE ANTERIOR VITREOUS ZONE WAS RESECTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 2 OF 4 REPORTS.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7939668 ↗
• InjuryOct 5, 2018Material Erosion; Flaked; Restricted Flow rate; Material Erosion; Flaked; Restricted Flow rate

  DURING A CATARACT PROCEDURE, A BROKEN POSTERIOR CAPSULE OCCURRED ON THE OPERATIVE EYE RESULTING IN A VITRECTOMY PROCEDURE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING THE IRRIGATION AND ASPIRATION PORTION, THERE WAS RESISTANCE THAT WAS CAUGHT AT THE PHACO TIP. IT WAS OBSERVED THAT THE GOLD COLOR SURFACE OF THE TIP SEEMED TO BE STRIPPING AWAY. THE BROKEN CAPSULE RESULTED IN A VITRECTOMY PROCEDURE AND THE ANTERIOR VITREOUS ZONE WAS RESECTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS 1 OF 4 REPORTS.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7939358 ↗
• InjuryDec 12, 2017Suction Problem; Suction Problem

  DURING A CATARACT EXTRACTION PROCEDURE, A HOSPITAL REPORTED THE POSTERIOR CHAMBER RUPTURED DURING THE IRRIGATION AND ASPIRATION SEGMENT. THE HOSPITAL INDICATED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE CAPSULAR BAG AS THERE WAS NO VITREOUS THAT CAME OUT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY PROBLEMS. THE HOSPITAL REQUESTED TO CHECK AND ADJUST THE VACUUM PRESSURE AND CHECK THE CONDITION OF THE TIP OF I/A. THIS REPORT IS FOR THE IRRIGATION/ASPIRATION (I/A TIP). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOFRAGMENTATION UNIT.

  Patient problems: Capsular Bag Tear

  MAUDE report 7111168 ↗
• InjuryDec 12, 2017Suction Problem; Suction Problem

  DURING A CATARACT EXTRACTION PROCEDURE, A HOSPITAL REPORTED THE POSTERIOR CHAMBER RUPTURED DURING THE IRRIGATION AND ASPIRATION SEGMENT. THE HOSPITAL INDICATED THE IOL WAS IMPLANTED OUTSIDE THE CAPSULAR BAG AS THE POSTERIOR CAPSULE SPLIT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY PROBLEMS. THE HOSPITAL REQUESTED TO CHECK AND ADJUST THE VACUUM PRESSURE AND CHECK THE CONDITION OF THE TIP OF I/A. THIS REPORT IS FOR THE IRRIGATION/ASPIRATION (I/A TIP). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PHACOFRAGMENTATION UNIT.

  Patient problems: Capsular Bag Tear

  MAUDE report 7111023 ↗