UNITY 00380650002969Recalls & reported problems

Summary

The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 00380650002969), received between Aug 25, 2024 and Sep 30, 2026 — classified as 46 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (81 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 271 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Capsular Bag Tear

  MAUDE report 50952764 ↗
• MalfunctionSep 29, 2026No Device Output

  A physician reported that an ophthalmic system exhibited no ultrasonic oscillation during surgery. The surgery was completed on the same day after the system was restarted and normal function was restored. The surgeon declined to provide any additional information.

  Patient problems: Insufficient Information

  MAUDE report 50931168 ↗
• InjurySep 24, 2026Restricted Flow rate; Air/Gas in Device

  A physician reported that during cataract surgery while using an ophthalmic system the phacoemulsification phase was completed without incident. During the cortex removal phase, reflux was unavailable despite the physician activating the foot pedal to the left approximately six to seven times. The physician continued attempting to activate reflux, after which a small surge of bubbles occurred in the eye and obstructed the surgical view. Subsequently, patient experienced zonular weakness and posterior capsular tear necessitating an anterior vitrectomy. As the patient had a history of glaucoma, and the patient was left aphakic. The patient underwent second surgery, and a sutured intraocular lens (IOL) was inserted on a different day. Current patient condition was unknown. Additional information has been requested but is not available at the time of this report.

  Patient problems: Capsular Bag Tear; Zonular Dehiscence

  MAUDE report 50885271 ↗
• MalfunctionSep 23, 2026Improper Flow or Infusion

  A customer reported that during a surgery in an ophthalmic system the anterior chamber (AC) was unstable and had aspiration issues. Additional information is requested but has not received till date.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 50866061 ↗
• MalfunctionSep 18, 2026Improper Flow or Infusion; Suction Failure

  A customer reported that an ophthalmic system exhibited inconsistent fluidics and aspiration. Procedure details and patient impact have not been provided. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50814738 ↗
• MalfunctionSep 17, 2026Suction Failure

  A physician reported that an ophthalmic console exhibited an aspiration issue (unknown mode) during surgery. The procedure details and patient impact were not reported. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50799863 ↗
• MalfunctionSep 16, 2026Improper Flow or Infusion; Suction Failure

  A healthcare professional reported that an ophthalmic system exhibited a sudden loss of aspiration and infusion functions during cataract surgery. The surgery was completed on the same day after restarting the system with a pack, and no further abnormalities were observed. Patient impact has not been provided. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50786250 ↗
• MalfunctionSep 11, 2026Loss of Power

  A customer reported that during surgery console has no laser power. Procedure details and patinet details were not reported. Additional information has been requested.

  Patient problems: Insufficient Information

  MAUDE report 50735610 ↗
• MalfunctionSep 7, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50649841 ↗
• InjurySep 5, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Capsular Bag Tear

  MAUDE report 50630012 ↗
• MalfunctionSep 4, 2026Improper Flow or Infusion

  Patient problems: Insufficient Information

  MAUDE report 50614966 ↗
• MalfunctionSep 4, 2026Unexpected Shutdown

  A Physician reported that ophthalmic console unexpectedly powered off while on standby during surgery. The console was recovered after the restart. Procedure details and patient impact have not been provided. No further information is expected, as the customer was unwilling to provide additional details.

  Patient problems: Insufficient Information

  MAUDE report 50611577 ↗
• MalfunctionSep 1, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539169 ↗
• MalfunctionAug 27, 2026No Device Output

  A customer reported that during surgery, an ophthalmic system had no phacoemulsification power in the middle of the case. Details of procedure was not reported. There was no patient impact. Additional information has been requested, but none received to date. This case pertaining to first of two patients from same facility.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472078 ↗
• MalfunctionAug 27, 2026No Device Output

  A Nurse reported that during intraocular lens implantation surgery, an ophthalmic operating system had no phacoemulsification power. The surgery was completed with alternative product. There was no patient impact. Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50468561 ↗
• MalfunctionAug 25, 2026No Device Output

  The healthcare professional reported that during cataract surgery ophthalmic console had no power in the middle of case. The procedure details and patient impact were not reported. Additional information has been requested, but none received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50429204 ↗
• MalfunctionAug 21, 2026Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372802 ↗
• MalfunctionAug 18, 2026Suction Problem; Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50298457 ↗
• MalfunctionAug 14, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249892 ↗
• 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.

  Patient problems: Anxiety

  MAUDE report 50210794 ↗
• 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 console involved for this reported event.

  Patient problems: Anxiety

  MAUDE report 50210792 ↗
• MalfunctionAug 11, 2026Accessory Incompatible; Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208295 ↗
• MalfunctionAug 7, 2026No Device Output; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176684 ↗
• InjuryAug 7, 2026Improper Flow or Infusion; Pressure Problem; Unexpected Shutdown; Suction Failure; Priming Problem

  A customer reported that during a vitrectomy procedure with silicone oil removal and endolaser treatment, the ophthalmic system exhibited a system message and shut down on two occasions while transitioning to the laser procedural step. Following each shutdown, infusion was lost, the patient experienced decreased intraocular pressure, and the surgeon observed softening of the patient's eye. The procedure was interrupted while the system was rebooted and reprimed. After the first event, replacement of the infusion tubing and vitrectomy probe was required to successfully complete priming. During the second event, the surgeon reported a more rapid loss of intraocular pressure, consistent with active aspiration of air or air backflow through the air infusion line. The current status of the patient was unknown.Additional information received that during the system message, the residual pressure loss was observed for ten to twenty seconds. The representative advised the physician to reboot the system. The surgeon manually assessed the eye before reboot and noted pressure loss, then performed manual air injection to maintain stability of the patient's eye. The fluidics management system (F

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 50176479 ↗
• MalfunctionAug 5, 2026Energy Output Problem

  A customer reported that an ophthalmic console exhibited with laser module failure and dim light during vitrectomy. Alternate system was brought to complete the surgery. There was no reports of patient harm.

  Patient problems: Insufficient Information

  MAUDE report 50144904 ↗