VERION™ 8065998270Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380659982705), received between May 18, 2021 and Sep 29, 2026 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Imprecision” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A non healthcare professional reported that system had off alignment as a result patient had to be brought back for lens rotation after refractive surgery in the unknown eye of the patient.The preoperative measurements did not match intraoperative measurements.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50929463 ↗
• InjuryFeb 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  A PHYSICIAN REPORTED THAT MISALIGNMENT WAS FOUND AFTER THE SURGERY AND ALIGNMENT CORRECTION WAS PERFORMED ON THE REVISION SURGERY FOR AXIS CORRECTION. THERE WAS A POSSIBILITY THAT SCAN OF A PATIENT'S EYE WAS NOT PERFORMED. THERE WAS NO PATIENT HARM AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24269288 ↗
• MalfunctionApr 18, 2024Imprecision; Imprecision

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS AN INCORRECT AXIS ALIGNMENT IN IMAGE GUIDANCE FOR THE PATIENT'S UNKNOWN EYE DURING INTRAOCULAR IMPLANTATION SURGERY. THE TORIC WAS MORE THAN THIRTY DEGREES OFF-AXIS. THE SURGEON STRONGLY BELIEVES THAT THE LENS DID NOT ROTATE AND THAT THEY MUST HAVE PLACED THE TORIC ON THE INCORRECT AXIS BEFORE NOTICING THE ISSUE WITH IMAGE GUIDANCE.

  Patient problems: Insufficient Information

  MAUDE report 19134768 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THEY DETECTED AN ANTERIOR CAPSULAR TEAR IN THE PATIENT'S LEFT EYE DURING TORIC ALIGNMENT WITH A TORIC OVERLAY. THE TEAR WAS FOUND TO BE IN LINE WITH THE INCISION AT ZERO DEGREES, WITH THE INTRAOCULAR LENS ALIGNED AT ONE EIGHTY DEGREES ALONG THE SAME AXIS AS THE OVERLAY DURING SURGERY. DURING A WITHDRAWING MOTION, THE SURGEON BELIEVES THEIR VIEW WAS OBSTRUCTED, LEADING TO UNINTENTIONAL CAPTURE OF THE ANTERIOR CAPSULE WITH THE INSTRUMENT, RESULTING IN THE TEAR. SURGEON FELT THAT THE TEAR'S INITIAL POINT WAS IN LINE WITH THE INCISION AT 0 DEGREES AND THE INTRAOCULAR LENS BEING ALIGNED AT 180 DEGREES ALONG THE SAME AXIS AS THE OVERLAY. THE SURGEON HAD PREVIOUSLY REQUESTED FOR THE OVERLAY TO BE MADE THINNER, WHICH WAS DONE AS INSTRUCTED. SURGEON WAS ALSO AWARE THAT MOVING THE SYSTEM STEP WOULD TURN OFF THE OVERLAY OR THAT THIS COULD BE REQUESTED IF NECESSARY. THERE WAS NO VITREOUS LOSS, AND NO VITRECTOMY WAS PERFORMED. THE PRIMARY INTRAOCULAR LENS WAS LEFT IN SITU, AND THE ANTERIOR CHAMBER WAS REFORMED, ALTHOUGH THE SURGEON IS UNCERTAIN AT THIS STAGE IF THERE IS SUFFICIENT CAPSULAR SUPPORT AND WHETHER A SECONDARY PROCEDURE MAY BE INDICATED. THEY W

  Patient problems: Capsular Bag Tear

  MAUDE report 19050211 ↗
• MalfunctionMar 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT A MICROSCOPE-INTEGRATED DISPLAY FAILURE OCCURRED, CAUSING THE DISPLAY GUIDE TO TURN ON AND OFF DURING AN UNSPECIFIED SURGERY ON THE PATIENT'S EYE. THE PROCEDURE WAS COMPLETED WITH MANUAL MARKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966897 ↗
• MalfunctionFeb 14, 2024Failure to Align; Failure to Align

  A HEALTHCARE PROFESSIONAL REPORTED THAT A RESIDUAL ERROR WITH POST OPERATIVE TREATMENT RESULTS WAS LESS THAN ONE DIOPTER, THE AXIS OFFSET BY NINETY DEGREES (OUT OF RANGE) IN THE LEFT EYE OF A PATIENT, AFTER SURGERY. AFTER SEVERAL ATTEMPTS TO ALIGN THE EYE AND WAS OFTEN OUT OF RANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18703617 ↗
• InjuryJan 9, 2024Failure to Align; Failure to Align

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DISCREPANCIES DURING THE SURGERY. AN ERROR MESSAGE "TRACKING OUT OF RANGE. ALIGN THE EYE" WAS DISPLAYED IN THE RIGHT EYE OF A PATIENT, DURING PROCEDURE. AS A RESULT, THE LENS WAS IMPLANTED ROTATED BY THIRTY DEGREES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18475069 ↗
• InjuryJan 4, 2024Imprecision; Imprecision

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS WAS FOUND PLACED IN THE WRONG AXIS IN AN UNIDENTIFIED EYE AFTER SURGERY. THE INTRAOCULAR LENS WAS RE-ROTATED. PATIENT SYMPTOMS WERE CONTINUING. THERE ARE TWO RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES PATIENT INITIALS (B)(6) UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18443247 ↗
• InjuryJan 4, 2024Imprecision; Imprecision

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS WAS FOUND PLACED IN THE WRONG AXIS IN AN UNIDENTIFIED EYE AFTER SURGERY. THE INTRAOCULAR LENS WAS RE-ROTATED. PATIENT SYMPTOMS WERE CONTINUING. THERE ARE TWO RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES PATIENT INITIALS DS UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18442673 ↗
• InjuryNov 21, 2023Imprecision; Imprecision

  A DOCTOR REPORTED THAT THE ASTIGMATISM REDUCTION EFFECT WAS INSUFFICIENT IN A PATIENT IN THE RIGHT EYE. A TORIC LENS WAS INSERTED USING THE SYSTEM, BUT THE ASTIGMATISM WAS NOT CORRECTED AFTER POST-CERTIFICATION. THE TORIC GUIDE WAS SO DIFFERENT THAT IT WAS VISUALLY OBVIOUS IT WAS INCORRECT. THE SURGERY WAS PERFORMED AND COMPLETED WITHOUT ANY REPORTED PATIENT HARM. INTRAOCULAR LENS TORIC AXIS CORRECTION WAS SUBSEQUENTLY PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182909 ↗
• MalfunctionNov 6, 2023Imprecision; Imprecision

  A CUSTOMER REPORTED THAT, DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SYSTEM DISPLAYED AN INCORRECT AXIS IN AN UNIDENTIFIED EYE AT AN UNKNOWN TIMING.

  Patient problems: Insufficient Information

  MAUDE report 18071241 ↗
• InjuryNov 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED USING THE SYSTEM SURGERY PLAN IN THE THEATER, BUT AN INCORRECT PATIENT WAS LOADED INTO THE SYSTEM IN THE UNKNOWN EYE DURING SURGERY. THE MARKER WAS SUCCESSFULLY REGISTERED, AND THE SURGERY WAS COMPLETED. THE PATIENT REPORTED A PROBLEM WITH THE TEAM TIME OUT, AS THE PATIENT WAS ALSO IMPLANTED WITH THE INCORRECT LENS, WHICH HAS SINCE BEEN EXPLANTED AND REPLACED. THE CLINICAL APPLICATION TEAM WILL FOLLOW UP WITH THE COMPLAINANT AND THE FACILITY. THE MEDICAL INTERVENTION WAS PERFORMED AND THE REPLACEMENT OF THE INCORRECTLY IMPLANTED HAS BEEN COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 18071185 ↗
• InjuryOct 16, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE REPORT OF MICROSCOPE-INTEGRATED DISPLAY WAS CAUSING THE REDUCED VIEW/LIGHT THROUGH THE SCOPE AND BECAUSE OF THAT IT WAS OUT OF THE SCOPE IN THE RIGHT EYE OF A PATIENT, DURING CATARACT SURGERY. THE PATIENT ENDED UP NEEDING ANTERIOR VITRECTOMY AND LENS WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 17937715 ↗
• MalfunctionOct 6, 2023Failure to Align; Failure to Align

  A HEALTHCARE PROFESSIONAL REPORTED A SITUATION WHERE THE GUIDANCE SYSTEM SHOWED INCORRECT INDICATIONS DURING SURGERY. THE SURGERY HAD TO PROCEED WITH MANUAL MARKING DUE TO THIS ISSUE. UNFORTUNATELY, LACK SPECIFIC INFORMATION REGARDING THE AFFECTED EYE AND THE PATIENT'S IDENTIFIER. DURING THE INITIAL SURGERY ON (B)(6) 2023, A TORIC INTRAOCULAR LENS WAS IMPLANTED BASED ON THE SYSTEM, BUT IT DID NOT EFFECTIVELY CORRECT THE ASTIGMATISM. THE PATIENT EXPERIENCED DIFFICULTY WITH THEIR VISION AS A RESULT. THEREFORE, ON (B)(6) 2023, THE SURGICAL TEAM REORIENTED THE AXIS OF THE LENS. DURING THIS REORIENTATION, IT WAS OBSERVED THAT THE INTRAOCULAR LENS ITSELF WAS NOT OFF-AXIS, AND THE SYSTEM DISPLAY INDICATED THE SAME LOCATION AS BEFORE. HOWEVER, WHEN MANUAL MARKING WAS PERFORMED, DISREGARDING THE SYSTEM, A MISALIGNMENT OF APPROXIMATELY TWENTY DEGREES WAS NOTED. FOLLOWING THE SURGERY, THE PATIENT'S VISION SIGNIFICANTLY IMPROVED, AND NO FURTHER COMPLAINTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886848 ↗
• MalfunctionSep 28, 2023Imprecision; Imprecision

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE TORIC OVERLAY DISPLAYED INCORRECT AXIS ALIGNMENT AND WAS ROTATED BY NINETY DEGREES FROM ITS ORIGINAL POSITION DURING A CATARACT PROCEDURE IN AN UNSPECIFIED EYE.

  Patient problems: Insufficient Information

  MAUDE report 17833132 ↗
• MalfunctionSep 22, 2023Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  A CUSTOMER REPORTED THAT FACING DIFFICULTY WITH REGISTERING AND TRACKING ISSUE AND SHOWING UNUSUAL BLACK RING OUTSIDE CENTRAL TRACKING AREA. ALSO FACING SCREEN FREEZE ISSUE IN THE RIGHT EYE OF A PATIENT, BEFORE CATARACT SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 17796707 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED A PATIENT WITH UNEXPECTED OUTCOME IN THE UNKNOWN EYE DURING INTRA OCULAR LENS IMPLANTATION. SURGEON HAD AN ISSUE WITH DIGITAL MARKER MICROSCOPE WAS NOT SHOWED CORRECT IMPLANTATION AXIS DURING SURGERY AND IMPLANTED THE LENS ON AXIS VIEWED WITH DIGITAL MARKER MICROSCOPE. THE PATIENT HAD TO BE BROUGHT BACK TO THE OPERATING ROOM FOR INTRA OCULAR LENS ROTATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17248590 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED PROBLEMS WITH THE DIGITAL MARKER MICROSCOPE, MEDICAL INTERVENTION WAS REQUIRED: TORIC REPOSITIONS IN THE UNKNOWN EYE OF A PATIENT, DURING SURGERY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15015361 ↗
• MalfunctionAug 2, 2021Failure to Align; Failure to Align

  A PHYSICIAN REPORTED THAT A FALSE AUTHENTICATION OF DIGITAL MARKER MICROSCOPE (DMM) HAD OCCURRED. THE DOCTOR INSERTED THE IOL ON THE AXIS AS INSTRUCTED, AFTER DMM AUTHENTICATION. POSTOPERATIVELY, AXIS MISALIGNMENT WAS FOUND, AND EVEN THOUGH DMM WAS AUTHENTICATED AGAIN, THE SAME AXIS AS THE FIRST TIME WAS DISPLAYED. THE DOCTOR GAVE UP (USING) THE DMM, AUTHENTICATED WITH ANOTHER PLANNER, AND FIXED THE IOL POSITION ACCORDING TO THE DISPLAYED AXIS, AND COMPLETED THE SURGERY. REPORTER INFORMED THAT THERE'S NO PATIENT HARM. REPORTER INFORMED THAT THERE MAY BE A POSSIBILITY OF MISAUTHENTICATION BY VERION. THE REPORTER THOUGHT THAT THE MEASURED VALUE OF VERION, BEFORE THE SURGERY, WAS ALSO WRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259448 ↗
• InjuryMay 18, 2021Failure to Align; Failure to Align

  A PHYSICIAN REPORTED THAT A PATIENT HAD AN INTRAOCULAR LENS (IOL) OFF AXIS BY AROUND 50 DEGREES, NOTED POSTOPERATIVELY. REPORTED ISSUE WAS STATED TO BE LIKELY RELATED TO CONFUSION ON THE DAY OF SURGERY AS GUIDANCE MAY HAVE BEEN SET INCORRECTLY, OR IOL MAY HAVE ROTATED SIGNIFICANTLY (AFTER IMPLANTATION), WHICH SEEMED UNLIKELY. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM ON A SEPARATE DAY AND INK MARKED, AND IOL WAS ROTATED INTO CORRECT AXIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11840485 ↗