TECNIS IOL DFR00V (REF DFR00VU220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 05050474750715), received between Oct 5, 2021 and May 30, 2025 — classified as 31 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Adverse 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 BLURRY VISION. THE ISSUE WAS NOTICED DURING POST-OP VISIT. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22118031 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE/DAMAGED AND THAT THE HAPTIC WAS DAMAGED. THEREFORE, A BACKUP LENS WAS USED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108465 ↗
• 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 LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Visual Disturbances

  MAUDE report 20206503 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS COMPLAINTS OF BLURRY VISION AND FEELS THAT THERE IS A WEB AROUND THE EYE. PATIENT STATED THAT THE DOCTOR TOLD HIM TO WAIT (01) ONE YEAR TO FILE A CLAIM WITH JNJ. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THE IOL WAS EXPLANTED AND REPLACED WITH A DIB00 22.0 DIOPTER IOL ON (B)(6) 2024 AND HAS NO ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 19356072 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR HAD TO EXPLANT THE TECNIS SYNERGY SIMPLICITY LENS AND COMPLETE A LENS EXCHANGE DUE TO POOR VISION, HALO AND GLARE. THERE WERE NO OTHER ISSUES AFTER IMPLANTATION OF SYNERGY LENS IN THE PATIENTS LEFT EYE. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/ SURGICAL INTERVENTIONS WERE REQUIRED. THE REPLACEMENT LENS WAS A PANOPTIX LENS. THE PATIENT WAS DOING GREAT POST OP. THE LENS IS NOT RETURNED AS IT WAS DISCARDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17819328 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT TECNIS SYNERGY SIMPLICITY INTRAOCULAR LENS (DFR00V) OF 22 DIOPTER WAS EXPLANTED FROM PATIENT'S RIGHT EYE AND REPLACED WITH TECNIS SIMPLICITY SYMFONY LENS (DXR00V), 21 DIOPTER IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATED THAT THE REASON FOR EXPLANT WAS POWER MISS. PATIENT HAD DRY EYE. THERE WAS NO INJURY. HOWEVER SUTURES WERE REPORTED. PATIENT IS IMPROVING. THE LENS WAS SCRAPPED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Dry Eye(s); Visual Impairment

  MAUDE report 17715930 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED DUE TO MECHANICAL FAILURE DESCRIBED LATER AS HALOS AND GLARE IN PATIENT'S RIGHT EYE INTERFERING WITH ALL DAILY ACTIVITIES. NEW INCISION WAS MADE AND LENS WAS REMOVED IN WHOLE, BUT NO VITRECTOMY OR SUTURES REQUIRED. IT WAS NOTED THAT THE REPLACEMENT IOL WAS AN AAB00, +22.0D POWER SIZE IOL. THE PATIENT'S VISION IS DOING WELL SINCE LENS REPLACEMENT AND NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17667367 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING "GHOST" VISION, WHERE OBJECTS LOOK WIDER THAN THEY ARE WITH THE IMPLANTED INTRAOCULAR LENSES (IOLS) IN BOTH EYES (OU). THE PATIENT HAS BEEN BACK TO THE DOCTOR SEVERAL TIMES AND HAS OBTAINED A SECOND OPINION, IN WHICH THE PATIENT WAS ADVISED TO USE PRISMS IN EYEGLASSES TO CORRECT THE VISION. THE PATIENT IS CONSIDERING GETTING A THIRD OPINION FROM A DIFFERENT DOCTOR. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT¿S EYES ARE NOT FOCUSING TOGETHER WHEN LOOKING AT THINGS. THE ISSUE WAS FURTHER DESCRIBED AS WHEN LOOKING AT A PERSON¿S HEAD, AN ADDITIONAL HEAD THAT IS SIX INCHES HIGHER WOULD BE SEEN OR WHEN LOOKING AT THE TV, A PORTION OF TWO SCREENS CAN BE SEEN. HOWEVER, IF THE PATIENT COVERS EACH EYE INDIVIDUALLY, EACH SINGLE EYE CAN SEE CLEARLY. AFTER THE FIRST IOL WAS IMPLANTED IN THE LEFT EYE (OS), THE PATIENT FELT THE VISION WAS GOOD. HOWEVER, ONCE THE RIGHT EYE (OD) IOL WAS IMPLANTED, THE PATIENT WAS UNABLE TO FOCUS THE EYES TOGETHER STARTING THE DAY THE EYE PATCH WAS REMOVED AFTER SURGERY. THE SURGEON INITIALLY TOLD THE PATIENT THAT THE ISSUE WAS SWELLING OF THE EYE, AND IT COULD TAKE UP TO 6 MONTHS TO RESOLVE, HOWEVER THE

  Patient problems: Swelling/ Edema; Visual Impairment

  MAUDE report 16531592 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING "GHOST" VISION, WHERE OBJECTS LOOK WIDER THAN THEY ARE WITH THE IMPLANTED INTRAOCULAR LENSES (IOLS) IN BOTH EYES (OU). THE PATIENT HAS BEEN BACK TO THE DOCTOR SEVERAL TIMES AND HAS OBTAINED A SECOND OPINION, IN WHICH THE PATIENT WAS ADVISED TO USE PRISMS IN EYEGLASSES TO CORRECT THE VISION. THE PATIENT IS CONSIDERING GETTING A THIRD OPINION FROM A DIFFERENT DOCTOR. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT¿S EYES ARE NOT FOCUSING TOGETHER WHEN LOOKING AT THINGS. THE ISSUE WAS FURTHER DESCRIBED AS WHEN LOOKING AT A PERSON¿S HEAD, AN ADDITIONAL HEAD THAT IS SIX INCHES HIGHER WOULD BE SEEN OR WHEN LOOKING AT THE TV, A PORTION OF TWO SCREENS CAN BE SEEN. HOWEVER, IF THE PATIENT COVERS EACH EYE INDIVIDUALLY, EACH SINGLE EYE CAN SEE CLEARLY. AFTER THE FIRST IOL WAS IMPLANTED IN THE LEFT EYE (OS), THE PATIENT FELT THE VISION WAS GOOD. HOWEVER, ONCE THE RIGHT EYE (OD) IOL WAS IMPLANTED, THE PATIENT WAS UNABLE TO FOCUS THE EYES TOGETHER STARTING THE DAY THE EYE PATCH WAS REMOVED AFTER SURGERY. THE SURGEON INITIALLY TOLD THE PATIENT THAT THE ISSUE WAS SWELLING OF THE EYE, AND IT COULD TAKE UP TO 6 MONTHS TO RESOLVE, HOWEVER THE

  Patient problems: Swelling/ Edema; Visual Impairment

  MAUDE report 16531520 ↗
• InjuryMar 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT POST-OPERATIVELY THE IOL (INTRAOCULAR LENS) DISLOCATED DUE TO BAG INSTABILITY. THE IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE REPLACEMENT LENS MODEL ZMA00 21.5 DIOPTER WAS PLACED INTO THE SULCUS. HOWEVER, IT ALSO DISLOCATED. THEREFORE, THE REPLACEMENT LENS WAS ALSO EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON (JNJ) IOL. THE NON-JNJ LENS WAS PLACED IN THE ANTERIOR CHAMBER. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16492658 ↗
• InjuryMar 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DFR00V 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF MECHANICAL FAILURE. THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER A NEW INCISION WAS CREATED. REPLACEMENT LENS INFORMATION AND PATIENT STATUS POST-LENS EXCHANGE ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479856 ↗
• InjuryJan 4, 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 THE PATIENT REPORTING DYSPHOTOPSIAS. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZCB00, SAME DIOPTER OF 22.0). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16098496 ↗
• InjuryDec 9, 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 THE PATIENT WAS NOT HAPPY WITH VISION OR SURGERY. THE PRODUCT IS NOT BEING RETURNED FOR EVALUATION. THERE WAS NO PATIENT INJURY AND NO REPORT OF ADDITIONAL INTERVENTION REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Discomfort

  MAUDE report 15955576 ↗
• InjuryOct 24, 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 THEM EXPERIENCING DYSPHOTOPSIA. CHIEF COMPLAINT IS BLURRY VISION, HALOS AND GLARE. THE COMPLAINT OF BLURRY VISION WAS AT ONE WEEK POST-OPERATION. THE EXPLANTED IOL WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. THE REPLACEMENT LENS IS A NON J&J IOL DIOPTER 21.5. REPORTEDLY, THERE WAS NO CAPSULE TEAR AND THE PATIENT IS DOING WELL, HAPPY WITH VISION.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15658708 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE DYSPHOTOPSIA AND BLURRY VISION IN THEIR LEFT EYE (OS) CAUSING EYE STRAIN, RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE PATIENT COULD NOT DRIVE AND NORMAL ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE INCISION WAS ENLARGED FOR THE EXPLANT, HOWEVER, NO OTHER SURGICAL INTERVENTIONS OR DELAY IN PROCEDURE REPORTED. A NON-JOHNSON AND JOHNSON LENS OF 21.5 DIOPTER WAS USED AS THE REPLACEMENT IOL. THE IOL WAS DISCARDED AND WILL NOT BE RETURNED FOR INVESTIGATION. THE PATIENT OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Eye Pain; Visual Disturbances

  MAUDE report 15299582 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE BLURRINESS, DYSPHOTOPSIA IN THEIR RIGHT EYE (OD) CAUSING EYE STRAIN, RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE INCISION WAS ENLARGED FOR THE EXPLANT; HOWEVER, NO OTHER SURGICAL INTERVENTIONS OR DELAY IN PROCEDURE REPORTED. A NON-JOHNSON AND JOHNSON LENS OF 21.5 DIOPTER WAS USED AS THE REPLACEMENT IOL. THE EXPLANTED IOL WAS DISCARDED AND WILL NOT BE RETURNED FOR INVESTIGATION. THE PATIENT OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Eye Pain; Visual Disturbances

  MAUDE report 15299333 ↗
• InjuryAug 25, 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 LEFT EYE DUE TO STARBURST, GLARE AND HALOS WHICH SHE COULD NOT TOLERATE. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/200 +2 AND THE POST-IMPLANTATION VISION WITH THE LENS WAS EXCELLENT WITH VISUAL ACUITY BEING 20/15. IT WAS NOTED THAT THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. NO OTHER INTERVENTIONS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 15293596 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DFR00V 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (OS), LEFT EYE. PATIENT REPORTS COMPLAINTS OF HALOS AND STARBURSTS. SHE WAS INFORMED SHE MIGHT SEE THEM, BUT SHE THOUGHT IT WOULD BE MAYBE ONE RING, NOT A RING, ANOTHER RING, AND ANOTHER RING ALL THE WAY DOWN TO THE GROUND. PATIENT ALSO REPORTS SHE CANNOT DRIVE AT NIGHT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING OS SYMPTOMS STARTED RIGHT AFTER THE SURGERY. IOL IS NOT BEING RETURNED AS IT REMAINS IMPLANTED IN THE PATIENT'S OS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo

  MAUDE report 15142714 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A VERY UNHAPPY PATIENT WITH A SYNERGY INTRAOCULAR LENS (IOL) IS GOING TO HAVE AN IOL EXCHANGE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS EXPLANTED IN THE PATIENT'S RIGHT EYE DUE TO BLURRED DISTANCE AND INTERMEDIATE VISION. THE LENS WAS DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING GOOD POST-OPERATIVELY. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15023353 ↗
• InjuryJun 28, 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 PATIENT EXPERIENCING VISUAL DISTURBANCES. THE PATIENT'S REPORTED PRE-OPERATIVE VISION WAS 20/50 -1 AND POST OPERATIVE 20/30 +2. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14847921 ↗
• InjuryJun 21, 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 AND ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER (DCB00, 22.5) WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTIONS WERE REQUIRED. THERE WAS NO ADVERSE EFFECT OR COMPLAINTS POST OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 14751139 ↗
• InjuryJun 7, 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 THE PATIENT COULD NOT TOLERATE THE LENS. THE PATIENT COULD NOT ADAPT TO IT DESPITE GIVING HER NEARLY 3 MONTHS. NO OTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE. IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT COULD NOT TOLERATE THE LENS. THE IOL EXCHANGE PROCEEDED UNEVENTFULLY AND THE NEW JOHNSON & JOHNSON DIB00 LENS WAS PUT IN THE BAG. NO OTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Discomfort

  MAUDE report 14627660 ↗
• InjuryJun 3, 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 LEFT EYE DUE TO HALOS AND VISUAL DISTURBANCES. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14599064 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN BOTH EYES, HOWEVER, THE PATIENT WAS HAVING VISION PROBLEMS IN THE LEFT EYE. THE PATIENT DID NOT SEE WELL AT DISTANCE WITH THE LEFT EYE AND WAS VERY FRUSTRATED AS IT TOOK SEVERAL MONTHS TO LET HER ADAPT. THE PATIENT WAS NOT HAPPY, HENCE, THE INTRAOCULAR LENS FROM THE LEFT EYE WAS EXPLANTED AND ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT TO HELP HER WITH DISTANCE. THE PATIENT IS NOW HAPPIER TO READ ROAD SIGNS AND HER READING IS NOW BETTER WITH THE RIGHT EYE. THERE WAS NO OTHER INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING WELL POST OPERATION. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14459594 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR DID BILATERAL ENHANCEMENTS ON A PATIENT WITH SYNERGY INTRAOCULAR LENSES (IOLS) TO BRING THEIR VISION INTO OPTIMAL FOCUS. THERE WAS NO ADVERSE EVENTS; HOWEVER, THE PATIENT REMAINED WITH VISUAL ISSUES OF BLURRY, UNCOMFORTABLE, AND BEING TREATED FOR DRYNESS. IT WAS FURTHER LEARNED THAT THE SUSPECT IOL FOR THE LEFT EYE (OS) WAS EXPLANTED MORE THAN 6 MONTHS POST IMPLANT DATE DUE TO BLURRY VISION. VITRECTOMY WAS ALSO PERFORMED. SUSPECT LENS WAS REPLACED WITH A 20.5 DIOPTER POWER NON JOHNSON AND JOHNSON IOL. PATIENT WAS NOTED TO BE DOING OKAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14439848 ↗