UNITY 00380650003157Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380650003157), received between Sep 23, 2024 and Sep 18, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Overheating of Device; Appropriate Device Problem Term/Code Not Available

  A customer reported that, an ophthalmic handpiece displayed a system messages, and the handpiece was slightly warm. The procedure completion details and patient impact have not been provided. Additional information requested, none received at this time of report.This is the first of two different handpiece reports received from the same facility.

  Patient problems: Insufficient Information

  MAUDE report 50813021 ↗
• MalfunctionSep 18, 2026Overheating of Device; Appropriate Device Problem Term/Code Not Available

  A customer reported that, an ophthalmic handpiece displayed a system messages, and the handpiece was slightly warm. The procedure completion details and patient impact have not been provided. Additional information requested, none received at this time of report.This is the second of two different handpiece reports received from the same facility.

  Patient problems: Insufficient Information

  MAUDE report 50812989 ↗
• MalfunctionSep 4, 2026Failure to Cut

  A customer reported that an ophthalmic handpiece had displayed system messages and also won't cut during cataract surgery. Details related to patient harm have not been reported. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50610930 ↗
• InjuryAug 11, 2026Appropriate Device Problem Term/Code Not Available

  A customer reported that there was display of error code during cataract surgery (with intra ocular lens implantation) surgery in the right eye of a male elderly patient. The incident resulted in prolonged delay in the start and progression of the surgical procedures causing anxiety in patient requiring supplemental sedation and oxygen therapy, as well as delaying their postoperative discharge. Although inpatient admission was not required; management was outpatient-based and the patient was prescribed with topical ophthalmic drops per standard post-cataract surgery protocol. There was no negative consequences on the patient and the patient was recovering.This report pertains to ophthalmic handpiece involved for this reported event.

  Patient problems: Anxiety

  MAUDE report 50210791 ↗
• InjuryJul 17, 2026Output below Specifications

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY ON THE LEFT EYE USING AN OPHTHALMIC SYSTEM AND OPHTHALMIC HANDPIECE, THE HANDPIECE UNDERPERFORMED DURING NUCLEUS SCULPTING. THE PHYSICIAN OBSERVED THAT IT CREATED UNEVEN, FLUFFY, AND LESS EFFICIENT GROOVES, MAKING NUCLEAR DISASSEMBLY MORE CHALLENGING AND LESS PREDICTABLE. THE PHYSICIAN ALSO REPORTED REPEATED OBSERVATIONS OF EXCESSIVE POSTERIOR CAPSULE SURGE CREATING AN UNSTABLE INTRAOCULAR ENVIRONMENT. THE SURGEON STATED THAT SYSTEM SETTINGS REQUIRE OPTIMIZATION AND THAT PARAMETERS WERE BEING ADJUSTED TO DETERMINE THE OPTIMAL SETTINGS. POSTOPERATIVELY, THE PATIENT EXPERIENCED CORNEAL EDEMA, POOR VISION, AND DELAYED VISUAL REHABILITATION IN THE EYE OPERATED ON USING THE OPHTHALMIC SYSTEM COMPARED WITH THE FELLOW EYE UNDERWENT SURGERY WITH ANOTHER OPHTHALMIC SYSTEM. THE PATIENT WAS TREATED WITH ISOLDE SALT SOLUTION DIRECTLY POSTOPERATIVE TO EXPEDITE RECOVERY FROM CORNEAL EDEMA AND TO REDUCE THE EXTENT. THE PATIENT SUBSEQUENTLY ACHIEVED IMPROVED VISION, AND NO PERMANENT CORNEAL ISSUES WERE REPORTED. THE PATIENT'S CONDITION WAS RESOLVED. THIS REPORT PERTAINS TO THE OPHTHALMIC HANDPIECE INVOLVED IN THE REPORTED EVENT AND REPRESENTS THREE

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 25857679 ↗
• InjuryJul 17, 2026Output below Specifications

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY ON THE LEFT EYE USING AN OPHTHALMIC SYSTEM AND OPHTHALMIC HANDPIECE, THE HANDPIECE UNDERPERFORMED DURING NUCLEUS SCULPTING. THE PHYSICIAN OBSERVED THAT IT CREATED UNEVEN, FLUFFY, AND LESS EFFICIENT GROOVES, MAKING NUCLEAR DISASSEMBLY MORE CHALLENGING AND LESS PREDICTABLE. THE PHYSICIAN ALSO REPORTED REPEATED OBSERVATIONS OF EXCESSIVE POSTERIOR CAPSULE SURGE CREATING AN UNSTABLE INTRAOCULAR ENVIRONMENT. . THE SURGEON STATED THAT SYSTEM SETTINGS REQUIRE OPTIMIZATION AND THAT PARAMETERS WERE BEING ADJUSTED TO DETERMINE THE OPTIMAL SETTINGS. POSTOPERATIVELY, THE PATIENT EXPERIENCED CORNEAL EDEMA, POOR VISION, AND DELAYED VISUAL REHABILITATION IN THE EYE OPERATED ON USING THE OPHTHALMIC SYSTEM COMPARED WITH THE FELLOW EYE UNDERWENT SURGERY WITH ANOTHER OPHTHALMIC SYSTEM. THE PATIENT WAS TREATED WITH ISOLDE SALT SOLUTION DIRECTLY POSTOPERATIVE TO EXPEDITE RECOVERY FROM CORNEAL EDEMA AND TO REDUCE THE EXTENT. THE PATIENT SUBSEQUENTLY ACHIEVED IMPROVED VISION, AND NO PERMANENT CORNEAL ISSUES WERE REPORTED. THE PATIENT'S CONDITION WAS RESOLVED. THIS REPORT PERTAINS TO THE OPHTHALMIC HANDPIECE INVOLVED IN THE REPORTED EVENT AND REPRESENTS ONE

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 25857444 ↗
• MalfunctionJul 10, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25777420 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING CHOP MODE OF CATARACT SURGERY AN OPHTHALMIC HANDPIECE AND SYSTEM WAS NOT GIVING CHAMBER STABILITY AND FLUCTUATION WHICH HAD OCCURRED IN MULTIPLE CASES. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND INDICATED THAT THE PATIENT EXPERIENCED CAPSULAR TEAR OR RUPTURE WHICH WAS MANAGED SURGICALLY BY ANTERIOR VITRECTOMY.

  Patient problems: Capsular Bag Tear; Intraocular Pressure Decreased

  MAUDE report 25111570 ↗
• MalfunctionFeb 5, 2026Improper Flow or Infusion

  A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED AN UNSTABLE ANTERIOR CHAMBER WHILE USING TWO OPHTHALMIC HANDPIECES DUE TO LOT OF ACTUATIONS. PROCEDURE DETAILS AND THE PATIENT¿S CURRENT CONDITION HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 24265740 ↗
• MalfunctionFeb 5, 2026Improper Flow or Infusion

  A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED AN UNSTABLE ANTERIOR CHAMBER WHILE USING TWO OPHTHALMIC HANDPIECES DUE TO LOT OF ACTUATIONS. PROCEDURE DETAILS AND THE PATIENT¿S CURRENT CONDITION HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 24265738 ↗
• MalfunctionSep 26, 2024Excessive Heating; Excessive Heating

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE WAS HEATED DUE TO STERILIZATION. THE HANDPIECE ALSO EXHIBITED SYSTEM MESSAGES. THE PROCEDURE DETAILS WAS NOT REPORTED. NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20308978 ↗
• MalfunctionSep 24, 2024Excessive Heating; Excessive Heating

  A CUSTOMER REPORTED THAT PHACOEMULSIFICATION HANDPIECE WAS FOUND TO BE HOT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20291424 ↗
• MalfunctionSep 23, 2024Excessive Heating; Excessive Heating

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC HANDPIECE WAS NOTED TO BE WARM AND DISPLAYED ERROR ADVISORIES. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20284446 ↗