CENTURION® 8065752914Recalls & reported problems

Summary

The FDA's MAUDE database contains 571 adverse event reports that list this exact device (DI 00380657529148), received between Mar 23, 2021 and Sep 28, 2026 — classified as 202 injuries, 369 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (118 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 571 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Device Output

  Patient problems: Insufficient Information

  MAUDE report 50924040 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that patients developed Toxic Anterior Segment Syndrome (TASS) following a procedure involving an ophthalmic handpiece. Procedure details and current condition of patients have not been provided. Additional information has been requested but is not available at the time of this report.Additional information received indicated that a cataract procedure on the right eye had been scheduled.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 50815342 ↗
• MalfunctionSep 15, 2026No Device Output

  A customer reported that during cataract surgery handpiece stopped working during phacoemulfication. Procedure was completed by using new handpiece and there was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772309 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the tenth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756252 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the nineth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756251 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the fourth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756250 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the eighth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756249 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the sixth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756247 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the twelfth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756245 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the third of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756244 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the fifth of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756243 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the second of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756242 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the eleventh of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50756241 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that, following cataract surgeries performed using an ophthalmic system and ophthalmic handpieces, multiple patients experienced significant corneal edema and swelling on postoperative day one. The physician stated that all 16 patients evaluated on the first postoperative day presented with significant corneal edema, reduced visual acuity of 20/100 or worse, at least 1+ Descemet¿s folds, and 1+ microcystic edema. The patients' current condition is unknown. The physician further reported that the ophthalmic system and handpieces successfully passed Prime and Tune testing, and no Advisory Codes were generated.It was reported that there was no indication that these handpieces were used in the procedures.This report pertains to the first of twelve different handpieces reported from the same facility.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Swelling/ Edema

  MAUDE report 50755946 ↗
• MalfunctionSep 9, 2026Particulates; Obstruction of Flow; Excessive Heating

  A customer reported that milky-white smoke, as described by the surgeon, came out of the tip of an ophthalmic handpiece during a cataract removal procedure with intraocular lens placement. The event occurred during the procedure while the system was in quadrant removal mode, and an occlusion message was displayed. The handpiece was removed and replaced with a different handpiece, and the procedure was completed on the same day. There was patient contact however, no visible patient impact was observed, and no additional medical intervention was required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50689251 ↗
• MalfunctionSep 4, 2026Excessive Heating

  FYI: A customer reported that ophthalmic system messages were displayed while using an ophthalmic handpiece and handpiece became hot. Procedure details and timing of the event are unknown. It is also unclear whether the surgery was completed. There was no patient impact. No further information was expected, as the customer was unwilling to provide additional details.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50608393 ↗
• MalfunctionAug 17, 2026No Device Output

  A customer reported that suction of an ophthalmic system stopped working in phacoemulsification and non-phacoemulsification mode. The procedure details and patient impact 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 50268748 ↗
• MalfunctionJul 31, 2026Suction Problem

  Patient problems: Eye Burn

  MAUDE report 50100266 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to second of the three handpieces used for the fifth of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50099185 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to one of the three handpieces used for the fifth of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50099183 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to third of the three handpieces used for the fifth of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50099182 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to third of the three handpieces used for the fourth of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50098940 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to one of the three handpieces used for the fourth of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50098935 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered. This report pertains to second of the three handpieces used for the fourth of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50098931 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to second of the three handpieces used for the third of five patients treated at the same facility.

  Patient problems: Blurred Vision; Corneal Edema; Corneal Scar

  MAUDE report 50096070 ↗