TECNIS IOL DFR00V (REF DFR00VU200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05050474750678), received between Nov 10, 2021 and Nov 19, 2024 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT IS EXPERIENCING RAINBOWS, HALOS AND STARBURST AROUND LIGHTS AND CHROME COLORED OBJECTS. PATIENT WAS DIAGNOSED WITH POSTERIOR CAPSULE OPACIFICATION AND HAD A YAG (YTTRIUM-ALUMINUM GARNET LASER TREATMENT). THE IMPLANTING DOCTOR INFORMED HER THAT SHE HAD ABNORMAL INFLAMMATION IN HER EYE AND REFERRED HER TO AN EXPERT. THE SECOND DOCTOR STATED THERE WAS NOTHING WRONG WITH HER EYES AND THAT IT WAS NORMAL INFLAMMATION. THE SYMPTOMS WERE NOTICED ¿RIGHT AFTER THE PROCEDURE¿ BUT THE EXACT DATE IS UNKNOWN. AFTER THE IMPLANTS SHE COULD NO LONGER DRIVE AT NIGHT. THE PATIENT REPORTED THAT THE ONLY REASON SHE DID THE IMPLANTS WAS FOR BETTER NIGHT VISION BUT IT¿S GOTTEN SIGNIFICANTLY WORSE SINCE THE IMPLANTS. SHE LIVES IN A PART OF THE COUNTRY WHERE IT GETS DARK VERY EARLY AND SHE CANNOT GO ANYWHERE UNLESS SHE IS DRIVEN. THE DOCTOR SAID HER BRAIN NEEDS TIME TO ADJUST BUT IT¿S BEEN TWO YEARS. THE PATIENT REVIEWED EXPLANTING THE IOLS WITH HER DOCTOR. REPORTEDLY, THE DOCTOR SAID, ¿IN 24 YEARS OF PRACTICE HE HAS NEVER SEEN A LENS REPLACEMENT AFTER A YAG.¿ THE DOCTOR SAID THAT HE C

  Patient problems: Flashers; Halo

  MAUDE report 20721056 ↗
• MalfunctionSep 5, 2024Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  RESISTANCE WAS REPORTED WITH THE BACK-UP PRE-LOADED DFR00V MODEL INTRAOCULAR LENS (IOL) #2 - SN: (B)(6). AFTER CLOSELY INSPECTING THE IOL, THE DOCTOR NOTED THE IOL WAS CRACKED WHILE IT WAS STILL IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT WITH THE IOL. THE PROCEDURE WAS COMPLETED USING A NON-JOHNSON & JOHNSON IOL #3 (VIVITY EDOF). NO FURTHER INFORMATION IS AVAILABLE. A SEPARATE REPORT WAS FILED FOR BACK-UP DFR00V MODEL INTRAOCULAR LENS (IOL) #1 - SN: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153478 ↗
• MalfunctionSep 5, 2024Break; Break

  THE PRE-LOADED DFR00V MODEL INTRAOCULAR LENS (IOL) #1 - SN: (B)(6) WAS REPORTED TO HAVE CRACKED IMMEDIATELY AFTER IT WAS INSERTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS REMOVED/EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL #3 (VIVITY EDOF). THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY DURING THE PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE. A SEPARATE REPORT WAS FILED FOR BACK-UP DFR00V MODEL INTRAOCULAR LENS (IOL) #2 - SN: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153386 ↗
• MalfunctionJun 26, 2024Break; Break

  A CRACK IN THE MIDDLE OF THE DFR00V MODEL INTRAOCULAR LENS (IOL) WAS NOTED AFTER IT'S IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS REMOVED AND A BACK-UP IOL WITH THE SAME MODEL AND DIOPTER SIZE, DFR00V 20.0 DIOPTER, WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT, NO INCISION ENLARGEMENT, NO SUTURE, AND NO VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620801 ↗
• InjuryApr 25, 2024Adverse 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 THE PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA. THE LENS WAS FULLY INSERTED AND REMOVED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE ISSUE WAS IDENTIFIED DURING POST-OPERATIVE EXAMINATION. THE PATIENT HAD DIFFICULTY SEEING AT WORK. THE PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/40. THERE WAS NO INCISION ENLARGED, NO SUTURES OR UNPLANNED VITRECTOMY REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19188460 ↗
• InjuryApr 25, 2024Adverse 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 THE PATIENT'S LEFT EYE DUE TO DYSPHOTOPSIA. THE LENS WAS FULLY INSERTED AND REMOVED IN A SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE ISSUE WAS IDENTIFIED DURING POST-OPERATIVE EXAMINATION. THE PATIENT HAD DIFFICULTY SEEING AT WORK. THE PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/25. THERE WAS NO INCISION ENLARGED, NO SUTURES OR UNPLANNED VITRECTOMY REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19188386 ↗
• InjuryApr 9, 2024Adverse 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 DYSPHOTOPSIAS /HALOS. THE PATIENT IS DOING WELL ON (B)(6) 2024 VISIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19068958 ↗
• InjuryJan 3, 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). PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED AS: ON (B)(6) 2023: DISTANCE VISUAL ACUITY (DVA): 20-25++ AND NEAR VISUAL ACUITY (NVA): 20/130. ON (B)(6) 2023: DVA 20/40 AND NVA: 20/30. ON (B)(6) 2023: DVA: 20/50- AND NVA 20/20. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED AND REPLACED WITH A DXR00V 20.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO DELAY IN PROCEDURE, NO MEDICAL ATTENTION, AND NO MEDICATION PRESCRIBED OUTSIDE OF STANDARD CARE HOWEVER UNPLANNED SUTURES WERE REQUIRED. POST-OPERATIVE BCVA WAS REPORTED AS: ON (B)(6) 2023: DVA: 20/40-2 AND NVA: 20/50. PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 18437020 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SIMPLICITY PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM LEFT EYE IN A SECONDARY SURGERY AND REPLACED WITH COMPETITOR LENS. PATIENT FEELS VISION WAS NOT AS CLEAR AS IT COULD BE. NOT ABLE TO READ WITHOUT READING GLASSES, CAN NOT SEE STREET SIGNS DUE TO BLURRINESS. NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. VISCOAT USED NO ENLARGEMENT OR VITRECTOMY OR SUTURES. POST-OPERATIVELY, PATIENT DOES NOT HAVE DEBILITATING CONDITION. PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS +0.50 +0.50 X 170 20/20. POST-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS NOT DONE YET. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18151414 ↗
• InjurySep 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 HALOS AND GLARE. THIS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO OTHER ADVERSE EVENTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17694508 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED 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 PATIENT COMPLAINTS OF NOT SEEING WELL AT NIGHT; IT IS UNKNOWN IF THE PATIENT'S DAILY ACTIVITIES WERE AFFECTED. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, DIFFERENT MODEL DIB00 AND DIFFERENT DIOPTER SIZE LENS, 19.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO PROCEDURE DELAY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER, IT IS UNKNOWN IF MEDICAL ATTENTION WAS REQUIRED OR IF MEDICATION WAS PRESCRIBED OUTSIDE OF STANDARD CARE. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17599757 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO PATIENT COMPLAINTS OF NOT SEEING WELL AT NIGHT; IT IS UNKNOWN IF THE PATIENT'S DAILY ACTIVITIES WERE AFFECTED. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, DIFFERENT MODEL AND DIFFERENT DIOPTER SIZE LENS, DIB00 19.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO PROCEDURE DELAY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER, IT IS UNKNOWN IF MEDICAL ATTENTION WAS REQUIRED OR IF MEDICATION WAS PRESCRIBED OUTSIDE OF STANDARD CARE. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17599203 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR PERFORMED LENS EXCHANGE ON PATIENT'S RIGHT EYE (OD) DUE TO VISUAL DISTURBANCE. IT WAS INDICATED THAT THE DOCTOR WILL WAIT FOR THE OUTCOME OF EXPLANT OF THE RIGHT EYE (OD) TO SEE IF IT HELPS IMPROVE THE PATIENT'S ISSUE AND DOCTOR DOES NOT KNOW YET BUT IF NO VISUAL IMPROVEMENT, THEY WILL MOVE TO NEXT STEP FOR EXPLANTING THE LENS IN THE LEFT EYE (OS). THE REPLACEMENT FOR OD IS DCB00 19.5 DIOPTER (D) SIZE LENS. FURTHER INFORMATION CONFIRMED THAT REPORT WAS ACTUALLY FOR A BILATERAL LENS (OU) EXPLANT. APPARENTLY LEFT LENS (OS) EXPLANT OCCURRED BEFORE THE RIGHT LENS (OD) EXPLANT. THE LENS IN THE LEFT EYE WAS REPLACED WITH A DCB00, 20.5D. REASON FOR BOTH EXPLANTS WAS VISUAL DISTURBANCE. UNKNOWN IF THERE WAS ANY INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. PATIENT IS DOING WELL ON BOTH POST-EXPLANTS. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT LENS (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT LENS (OS).

  Patient problems: Visual Disturbances

  MAUDE report 17390835 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT DFR00VU200 INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S EYE DUE TO INTOLERABLE VISUAL DISTURBANCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17295005 ↗
• InjuryJul 10, 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). PATIENT COMPLAINS OF BLURRY VISION IN DISTANCE AND INTERMEDIATE AND HAVING HARD TIME WATCHING TELEVISION. PATIENT HAD INADEQUATE VISION FOR DRIVING AND PATIENT WAS HAVING A HARD TIME SEEING STREET SIGNS UNTIL ALMOST PAST THEM AND GLARE COMING FROM HEADLIGHTS. GLARE ALSO HAPPENS WITH ARTIFICIAL LIGHT AND SUNLIGHT. HALOS BOTH NIGHT AND DAY AND LEFT EYE HAD DOUBLE VISION. GLASSES DID NOT HELP. IOL EXPLANT SCHEDULED FOR (B)(6) 2023. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED THAT THE IOL WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 20.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS PATIENT DOING WELL AT 1-DAY POST-OPERATIVELY. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17294338 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD HER BILATERAL INTRAOCULAR LENSES (IOLS) EXPLANTED BY ANOTHER SURGEON. PATIENT HAD BEEN EXPERIENCING GLARE AND HALOS, STARBURSTS AROUND LIGHTS AT NIGHT AND SPIKES AND ALL SORTS OF REFRACTION ISSUES AND EYESIGHT HAS DETERIORATED OVER TIME AND COULD NOT SEE 15 FEET IN FRONT OF HER. NIGHT DRIVING FROM GLARE IS BLINDING AND IMPOSSIBLE TO DRIVE AT NIGHT. ALL LIGHTS, HEADLIGHTS, TAILLIGHTS, STREETLIGHTS, HOUSE LIGHTS ALL HAD A COMBINATION OF HALOS, SPIRALS, STARBURSTS, AND FERRIS WHEELS. SOUTHERN EYE CENTER REMOVED BOTH IOLS RECENTLY. PATIENT IS LOOKING TO GET REIMBURSEMENT FROM PHYSICIAN BUT HAS NOT TOLD PHYSICIAN YET. IT WAS LEARNED THAT THE EXPLANTED IOLS WERE REPLACED WITH NON-JOHNSON AND JOHNSON IOLS. CUSTOMER SAID THAT HER VISION IS A LOT BETTER THAN WHEN SHE HAD THE OLD LENSES. CUSTOMER CONFIRMED THAT SHE HAS BOTH EXPLANTED IOLS WITH HER AND WILL GIVE THEM TO HER IMPLANT DOCTOR ONLY IF SHE WILL REIMBURSE HER WITH HER EXPENSES. OTHERWISE, SHE WILL NOT RETURN THE PRODUCTS FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR LEFT EYE. A SEPARATE REPORT IS SUBMITTED FOR THE OTHER EYE (RIGHT EYE).

  Patient problems: Flashers; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16766196 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE HAD A YAG (YTTRIUM-ALUMINUM-GARNET) CAPSULOTOMY WAS PERFORMED ON (B)(6) 2022, HOWEVER, THE PATIENT CONTINUES TO EXPERIENCE DISABLING GLARE AND HALOS FROM THE LENS. PLAN IS TO EXPLANT THE LENS ON (B)(6) 2023 AT MASS EYE AND EAR (DIFFERENT FACILITY). THERE IS NO PATIENT INJURY. THE LENS REMAINS IMPLANTED AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16315833 ↗
• InjuryOct 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 FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT'S DISTANCE VISION WAS NOT CRISP AND WAS NO LONGER ABLE TO DRIVE AT NIGHT DUE TO SIGNIFICANT GLARE AND STARBURSTS. THE PATIENT TRIED TO GET USED TO THE NEW IOL FOR FIVE MONTHS, BUT JUST NOT ABLE TO LIVE NORMALLY WITH GLARE AND HALOS EVEN WITH THE EXCELLENT OUTCOME. PATIENT OUTCOME: 20/20 NEAR VISION (NV) 5 PT, VISUAL ACUITY PRE-OPERATIVE (OP): +.75 SPHERICAL (SPH) 20/20; POST-OP VISION -0.25 -0.25 X 14 20/20 NV 5 PT SC (WITHOUT CORRECTION).THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED. A VITRECTOMY WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS PROVIDED THAT A NON-JOHNSON & JOHNSON LENS OF 19.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME AT 1 DAY POST-OP VISIT ONLY SO FAR, 20/40 UCDV (UNCORRECTED DISTANCE VISION). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 15578369 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STROBE LIGHTS, STARBURSTS, AND GLARE AT NIGHT IN THEIR LEFT EYE (OS) RESULTING IN THE NEED TO EXPLANT THE INTRA-OCULAR LENS (IOL). THE REPLACEMENT IOL IS OF A DIFFERENT MODEL AND DIOPTER. THERE WAS NO REPORTED PATIENT INJURY AND NO ISSUES ARE REPORTED WITH THE PATIENT POST-OPERATION. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 15452221 ↗
• InjuryAug 29, 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 VISUAL ISSUES OF DEBILITATING HALOS AND GLARE. THE EXPLANTED LENS WAS REPLACED WITH A DCB00, 20.0D, WITH NO ADVERSE EVENTS. THE PATIENT WAS DOING WELL POST-OP. THE SUSPECT LENS UNKNOWN IF COMING BACK TO JOHNSON AND JOHNSON FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15317314 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO "MECHANICAL COMPLICATIONS." THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE "MECHANICAL FAILURE" WAS DETERMINED BY THE PATIENT'S INABILITY TO ADAPT TO THE CONSTANT HALOS WITH DAYTIME AND NIGHTTIME VISION ESPECIALLY WHEN DRIVING. THE INCISION WAS ENLARGED. NO VITRECTOMY OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, AAB00, DIFFERENT DIOPTER, +19.50). THE PATIENT HAS STABLE POST-OPERATIVE FINDINGS AND VISION IS IMPROVING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 15061247 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENSES (IOLS) WERE EXPLANTED FROM PATIENT'S BOTH EYES DUE TO BLURRY VISION, LIGHT SENSITIVITY AND SEVERE HALOS. THE PATIENT WAS UNABLE TO DRIVE SINCE THE INITIAL IMPLANT. THERE WAS NO PATIENT INJURY. THE PATIENT WAS HAPPY POST-OPERATION AND STATED THAT SHE COULD SEE BETTER. THE ORIGINAL LENSES WERE DISCARDED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE LENS EXPLANTED FROM PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED AGAINST THE LENS EXPLANTED FROM THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14719745 ↗
• InjuryMay 4, 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 MECHANICAL COMPLICATIONS. IT WAS LEARNED THAT WHAT THE CUSTOMER MEANT BY MECHANICAL COMPLICATION WAS VISUAL ISSUES OF HALOS AND GLARE. THERE WAS NO CAPSULE TEAR REPORTED, NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. SUSPECT IOL WAS REPLACED WITH ANOTHER MODEL IOL (DIB00), 20.0 DIOPTER POWER. THE PATIENT WAS STABLE POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14283802 ↗
• InjuryApr 6, 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 (OD) EYE AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS, LENS FROM BAUSCH AND LOMB MODEL LI61AO WITH 20.5 DIOPTER POWER, IN A SECONDARY PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. REPORTEDLY, THE PATIENT IS DOING FINE POST-SURGERY. THE LENS HAS BEEN DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14028189 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO DYSPHOTOPSIA CAUSING PATIENT TO BE VERY UNHAPPY. SYMPTOMS INCLUDED VISUAL FOG, SEVERE HALOS AT NIGHT, CONTRAST SENSITIVITY LOSS, AND GENERAL DECREASE IN ACUITY. THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH PATIENT'S ACTIVITIES OF DAILY LIFE. THE REPLACEMENT LENS IS A DIB00, +21.5 DIOPTER. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13961809 ↗