TECNIS IOL DFR00V (REF DFR00VU215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05050474750708), received between Nov 18, 2021 and Sep 12, 2024 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED OF A PLANNED EXPLANT OF A MULTIFOCAL INTRAOCULAR LENS (IOL) FROM AN UNHAPPY PATIENT'S EYE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LENS ON THE LEFT EYE WAS EXPLANTED. IT WAS PLANNED THE FOLLOWING WEEK TO REMOVE THE IOL OF THE RIGHT EYE AS WELL. THE REASON FOR EXPLANT WAS DUE TO MAJOR VISUAL DYSPHOTOPSIAS. IT WAS LEARNED THAT THE PATIENT DID NOT LIKE VISION WITH SYMFONY, SO THEY REPLACED THEM WITH DIB00. THE PATIENT FULLY RECOVERED POST EXPLANT, PRE-OP BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) - 20/40, POST-OP BSCVA - 20/20 NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES AND NO DELAY IN PROCEDURE REPORTED. EXPLANTED LENS WILL NOT BE SENT BACK. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Visual Disturbances

  MAUDE report 20205932 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MULTIFOCAL INTRAOCULAR LENS HAD EXPLANTED DUE TO REFRACTIVE SURPRISE. IT WAS REPLACED IN SECONDARY SURGICAL PROCEDURE WITH ANOTHER COMPANY IOL. NO INJURY AND SURGICAL AND MEDICAL INTERVENTION REQUIRED. PRODUCT IS AVAILABLE TO RETUNE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 19388866 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S EYE DUE TO DYSPHOTOPSIA. NO INFORMATION ABOUT REPLACEMENT IOL. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18850068 ↗
• MalfunctionDec 12, 2023Break; Break

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACE WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER BECAUSE THE LENS WAS DAMAGED BY THE INSERTER. THERE WAS NO VITRECTOMY REQUIRED AND NO SUTURE WAS USED. NO PATIENT HARM REPORTED. THE LENS WAS NOT SAVED AND WILL NOT BE RETURNING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315753 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE, DUE TO MECHANICAL COMPLICATIONS, DESCRIBED AS UNSPECIFIED INJURIES. THERE WAS INCISION ENLARGEMENT. A JOHNSON & JOHNSON MONOFOCAL LENS, MODEL DCB00 OF THE SAME DIOPTER POWER (21.5 D) WAS USED AS A REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18221203 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOUR TO SIX WEEKS AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT EXPERIENCED INTOLERABLE DYSPHOTOPSIA. AN EXPLANT WAS PLANNED FOR (B)(6), 2023. NO MEDICAL OR SURGICAL INTERVENTION HAS PERFORMED YET. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT THE EXPLANT WAS SUCCESSFULLY PERFORMED ON (B)(6), 2023. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (EYHANCE IOL). THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS GOOD. THE IMPLANT DATE WAS A FEW MONTHS PRIOR TO THE EXPLANT DATE (EXACT DATE OF IMPLANT IS UNKNOWN). THE PATIENT'S SYMPTOMS OF DYSPHOTOPSIA/VISUAL DISTURBANCE STARTED A FEW MONTHS PRIOR TO THE EXPLANT DATE AND THE PATIENT REQUESTED THE LENS TO BE EXPLANTED DUE TO THE SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17656232 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF BLURRY DISTANCE VISION AND SOME GLARE AND HALOS NOTICED AT 1 WEEK POST-OP EXAM. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION 20.5 DIOPTER IOL. THERE WAS NO PATIENT INJURY AND NO VITRECTOMY HOWEVER, THERE WAS A VERY SMALL INCISION ENLARGEMENT AND ONE (01) UNPLANNED SUTURE WAS REQUIRED FOR THE IOL EXCHANGE PROCEDURE. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS DOING BETTER SINCE EXCHANGE AND DOING WELL WITH MONOFOCAL IOL REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 17628261 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO INTOLERABLE GLARE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL DIB00, DIFFERENT DIOPTER, 20.0). THERE WAS NO PATIENT INJURY. THERE WAS NO INDICATION THAT ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. IT IS "TO BE DETERMINED" HOW THE PATIENT IS DOING POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16440684 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL FAILURE WHICH WAS DIAGNOSED ON (B)(6) 2022. FURTHER INFORMATION NOTED THAT THE MECHANICAL FAILURE WAS DESCRIBED AS PATIENT HAD BLURRY VISION, UNABLE TO READ OR SEE CLEARLY. EXPLANTED IOL WAS REPLACED WITH AAB00 +22.5 DIOPTER SIZE IOL. THERE WAS NEW INCISION MADE AND THE LENS WAS REMOVED WHOLE, BUT NO VITRECTOMY AND NO SUTURES PERFORMED. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 16308736 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FULLY INSERTED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DURING A SECONDARY SURGERY. THE ISSUE WAS FIRST IDENTIFIED AFTER IMPLANTATION. NO MEDICAL ATTENTION WAS SOUGHT. NO INCISION ENLARGEMENT, SUTURE, OR VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT WAS VERY UNHAPPY WITH OS VISION. THE PATIENT WAS EXPERIENCING GHOSTING OF LETTERS AND FELT THAT THE READING VISION WAS COMPROMISED, HOWEVER THE PATIENT REPORTED THAT OS DISTANCE VISION WAS FINE. THE PATIENT ALSO REPORTED HALOS WHEN DRIVING AT NIGHT TIME. THE PATIENT'S SYMPTOMS OF HALOS WERE FIRST NOTED ON (B)(6) 2022. A NON JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT DIOPTER OF +20.5). THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING GREAT POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15897430 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE JNJ IOL, THE PATIENT EXPERIENCED BLURRY VISION. THE ISSUE WAS REPORTED ONE DAY POST-OP. THE IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT MULTIFOCAL LENS. THE PATIENT IS DOING WELL POST-OP. THEY HAVE FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15897420 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED AS THE DISTANT VISION ON THE LEFT EYE WAS NOT CLEAR. A NON-JOHNSON AND JOHNSON LENS WAS USED AS THE REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15883132 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE. THE REASON FOR THE EXPLANT WAS NOT UNSPECIFIED. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15459961 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT COMPLAINED OF NEGATIVE DYSPHOTOPSIA. THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES. THE IOL WAS EXPLANTED. A NON-JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIOPTER 20.5). NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED OR PLANNED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15280317 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO PATIENT COMPLAINT OF BLURRY VISION. THE LENS WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14960911 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROVIDER REPORTED THAT THEY EXPLANTED AN INTRAOCULAR LENS (IOL) FROM A PATIENT'S RIGHT EYE DUE TO THE PATIENT¿S HYPEROPIC OUTCOME RESULTING IN THEIR DISTANCE VISION BEING BLURRY. THE SYMPTOMS WERE DEBILITATING. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, SUTURES OR MEDICATION OUTSIDE OF THE STANDARD OF CARE. THE REPLACEMENT LENS WAS THE SAME MODEL DFR00V, BUT A DIFFERENT DIOPTER 22.0. REPORTEDLY, THE EXPLANTED IOL WILL NOT BE RETURNED DUE TO THE CUSTOMER'S PROCEDURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14866604 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE PATIENT COMPLAINED OF HALOS AND LIGHT SENSITIVITY. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. A COMPETITOR LENS WAS USED AS THE REPLACEMENT. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14849147 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE AFTER THE PATIENT WAS UNABLE TO ADAPT TO THE IOL. THE PATIENT EXPERIENCED SUBJECTIVE DYSPHOTOPSIA, VISUAL DISTURBANCES, WHICH PERSISTED FOR THREE MONTHS. DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE SYMPTOMS WERE INITIALLY OBSERVED DURING A POST-OPERATIVE EXAMINATION. NO VITRECTOMY, SUTURES, INCISION ENLARGEMENT, OR MEDICATION WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE END-USER DID NOT SEEK ANY MEDICAL ATTENTION. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS A REPLACEMENT LENS (DIFFERENT MODEL, DIBOO, SAME DIOPTER). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14197773 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, DIFFERENT DIOPTER OF +22.5).THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 14062138 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO MECHANICAL COMPLICATIONS. IT WAS LEARNED THAT THE MECHANICAL COMPLICATIONS ARE DESCRIBED AS PATIENT WITH BLURRED VISION FLUCTUATING THROUGHOUT THE DAY AND BEING UNABLE TO SEE STREET SIGNS. THE INCISION WAS ENLARGED DURING THE EXPLANT. SUSPECT IOL WAS REPLACED WITH ANOTHER MODEL, AAB00, +20.5 DIOPTER. THERE WERE NO OTHER INTERVENTIONS SUCH AS VITRECTOMY OR SUTURES REQUIRED. THE PATIENT WAS IN A STABLE CONDITION POST-OP AND NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13973932 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO BLURRED VISION (COULD NOT SEE LEAVES ON TREES) AND A DARK CRESCENT AROUND THE LEFT EYE LENS. THE SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL, DIOPTER SIZE WAS NOT PROVIDED. THERE WAS NO ADVERSE EVENTS, PATIENT DOING OK POST-EXPLANT. IT WAS STATED THAT NO FURTHER INFORMATION IS AVAILABLE, NO FOLLOW-UP NEEDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13905349 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO VISUAL ISSUES. THE COMPUTER DISTANCE WAS NOT GOOD, AND THE LONG DISTANCE WAS FUZZY. A COMPETITOR LENS OF 22.0 DIOPTER WAS USED AS THE REPLACEMENT AND NO MEDICAL OR SURGICAL NTERVENTIONS WERE REQUIRED. THE PATIENT WAS DOING GREAT POST OPERATION. (B)(6) 2021, PRE-OPERATIVE UNCORRECTED VISUAL ACUITY (UCVA) WAS 20/30 -2 J16 AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/25. (B)(6) 2021, POST-OPERATIVE UNCORRECTED VISUAL ACUITY (UCVA) WAS REPORTED TO BE 20/25 +1 AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20. THE PATIENT NEXT VISIT IS ON (B)(6) 2022.NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13835659 ↗
• InjuryMar 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE PATIENT WAS DISSATISFIED AS THE VISION WAS NOT CLEAR AND HALOS WERE BOTHERSOME. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT AND THE PATIENT WAS DOING GOOD POST EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 13748726 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS 20/20 J1 BUT NEVER ADJUSTED TO GLARE AND HALOS AFTER THE IMPLANTATION OF THE SYNERGY INTRAOCULAR LENSES (IOL) IN BOTH EYES. THERE WAS NO REFRACTIVE ERROR, OR RESIDUAL ASTIGMATISM. THE LENSES WERE EXCHANGED TO NON-JOHNSON AND JOHNSON MONOFOCAL LENSES. NO COMPLICATIONS WERE OBSERVED DURING THE EXCHANGE PROCEDURES DESCRIBED AS BEING ROUTINE SURGERIES. PATIENT OUTCOME WAS REPORTED AS HAVING NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. IT WAS UNKNOWN FROM WHICH EYES THE LENSES WERE EXPLANTED. THIS REPORT REPRESENTS THE RIGHT (OD) AND A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT (OS) EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13529078 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO BLURRY VISION AT DISTANCE. UPON FURTHER FOLLOW-UP IT WAS LEARNED THAT THE REPLACEMENT LENS WAS A NON- JOHNSON & JOHNSON LENS. THERE WAS FURTHER ISSUES REPORTED. THE PATIENT WAS REPORTEDLY HAPPY WITH THE NEW LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13233309 ↗