ONE SERIES ULTRA 1VIPR30Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474534605), received between Jun 12, 2017 and Dec 23, 2020 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING SURGERY THE TRAILING HAPTIC OF AN INTRAOCULAR LENS (IOL) GOT STUCK IN THE INJECTOR AND BROKE. THE SURGEON REMOVED THE IOL AND COMPLETED THE SURGERY WITH THE STANDBY LENS OF THE SAME MODEL LENS BUT A DIFFERENT DIOPTER (23.0) WITH THE SAME INJECTOR AND A DIFFERENT CARTRIDGE. THERE WAS A 30 MINUTE DELAY IN TREATMENT WHICH THE INCISION WAS ENLARGED TO CUT AND REMOVE THE LENS FROM THE EYE. SUTURES WERE REQUIRED AT THE END OF THE SURGERY. IT WAS REPORTED THAT CURRENTLY THE PATIENT DOES NOT HAVE ANY COMPLAINT WITH THE VISION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 11062197 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED RECEIVING INFORMATION VIA SOCIAL MEDIA REGARDING INTRAOCULAR INFLAMMATION (FIBRIN AND ENDOPH (ENDOPHTHALMITIS) LIKE RELATED TO A BATCH OF 1VIPR30 CARTRIDGES. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION TO CLARIFY THE EVENT, HOWEVER NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Endophthalmitis; Inflammation

  MAUDE report 9556245 ↗
• MalfunctionApr 30, 2019Crack; Crack

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO CARTRIDGE TIP CRACKED OR DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8563602 ↗
• MalfunctionFeb 16, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED 1VIPR30 CARTRIDGE WAS SPLIT AT THE CARTRIDGE TIP DURING INSERTION. IT WAS REPORTED THE LENS WAS NOT DAMAGED AND THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346378 ↗
• MalfunctionAug 24, 2018Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF A 1VIPR30 CARTRIDGE WAS CRACKED DURING HANDLING AND PRIOR TO INSERTION. REPORTEDLY, IT HAD A SPLIT SUPERIORLY ALONG THE TOP OF THE CARTRIDGE EXTENDING THE LENGTH OF THE PIECE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7815498 ↗
• InjuryJan 10, 2018Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT A ZCB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS STUCK IN A 1VIPR30 CARTRIDGE DURING INSERTION INTO THE PATIENT'S OPERATIVE EYE. AN INCISION ENLARGEMENT WAS THEN MADE TO REMOVE THE CARTRIDGE SAFELY. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE REPLACEMENT LENS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7181221 ↗
• MalfunctionSep 12, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DOCTOR SAW TWO SMALL SPOTS OF CARTRIDGE LUBRICANT ON AN INTRAOCULAR LENS (IOL) AFTER THE LENS WAS IMPLANTED. THE LENS WAS IMPLANTED IN THE LEFT EYE WITH USE OF A MODEL 1VIPR30 CARTRIDGE WITH A DK7791 TWIST INSERTER. REPORTEDLY, THERE WAS NO PATIENT COMPLICATION OR INJURY AND THIS WAS NOT INTERFERING WITH ACTIVITIES OF DAILY LIFE. THE INTRAOCULAR LENS REMAINS IMPLANTED. THE PATIENT VISITED THE DOCTOR 1 DAY AFTER SURGERY AND IS NORMAL WITH AN UNCORRECTED DISTANCE VISUAL ACUITY OF 20/30 -2 ON THE SNELLEN CHART. ALSO, THE PATIENT HAD NO OCULAR SYMPTOM COMPLAINTS. MEDICAL FINDINGS OF +1 CELLS AND A SMALL CORTICAL REMNANT WAS NOTED OUT OF THE VISUAL FIELD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation

  MAUDE report 6860659 ↗
• MalfunctionJun 12, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CARTRIDGE TIP DEFORMED DURING INTRAOCULAR LENS (IOL) IMPLANTATION. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6635320 ↗