TECNIS IOL ZLB00 (REF ZLB00U0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 05050474560703), received between Aug 25, 2016 and May 6, 2024 — classified as 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZLB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS COMPLAINTS OF BLURRINESS AND DISTORTION THAT HAS PROGRESSIVELY GOTTEN WORSE. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE REPORTED EVENT. IOL EXPLANT IS SCHEDULED FOR (B)(6) 2024. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED ON (B)(6) 2024. THE EXPLANTED IOL WAS REPLACED WITH A ZLU150 21.5 DIOPTER IOL. THERE WAS NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS EXCELLENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19249758 ↗
• InjuryApr 25, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS INSERTED IN THE EYE AND THE CAPSULE WAS SPONTANEOUSLY BROKEN. THE LENS WAS CUT OUT AND REMOVED. THE WOUND WAS ENLARGED AND A NON-JOHNSON AND JOHNSON IOL WAS INJECTED. THE SURGEON TOLD THE PATIENT THAT THE LEFT EYE DID NOT HAVE THE SUPPORT TO PUT IN THE LENS, SO A NON-JOHNSON AND JOHNSON IOL HAD TO BE PLACED IN THE SULCUS THE NEXT DAY, AT POST-OP DAY 1 VISIT, THE SURGEON TOLD THE PATIENT THAT UP UNTIL INSERTING THE LENS IN THE LEFT EYE, THE SURGERY "WAS TEXTBOOK". HOWEVER, WHEN THE LENS WAS INSERTED THE CAPSULE TORE DUE TO THE LENS NOT UNFOLDING; THE LENS TORE THE CAPSULE. THE PATIENT REPORTED BEING TOLD THAT THE LENS WAS CUT OUT OF EYE BECAUSE THE LENS WAS FLOATING TOWARDS THE RETINA. THE PATIENT NOTED THAT THE RIGHT EYE CATARACT SURGERY WAS DONE YEARS AGO AND THIS LEFT EYE SURGERY FELT VERY DIFFERENT THAN THE PREVIOUS SURGERY ON THE OTHER EYE, IN THAT THIS SURGERY WAS PAINFUL. THE PATIENT HAD PRE-OPERATIVE VISUAL ACUITY OF 20/300. THE PATIENT REPORTED THAT SHE DOES NOT HAVE ANY PRE-EXISTING OCULAR CONDITIONS. THE PATIENT WAS TOLD THAT THE REMOVED JOHNSON AND JOHNSON LENS WAS DESTROYED. WITH THE IMPLANTED NON-JOHNSON

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 16811061 ↗
• InjuryFeb 17, 2023Adverse 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 LEFT EYE (OS), THE PATIENT EXPERIENCED BLURRED VISION. THE PATIENT HAD "LASER WORK" DONE ON (B)(6) 2022 BUT REPORTED "IT DID NOT WORK." THE PATIENT WAS TOLD THERE IS AN ASTIGMATISM AND WILL BE RETURNING TO THE SURGEON FOR FOLLOW-UP IN (B)(6) 2023. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS TOLD BY THE SURGEON THAT GLASSES WOULD NEVER BE NEEDED TO SEE AFTER THE CATARACT SURGERY AND IOL IMPLANT. SOMETIME AFTER HAVING THE LENS IMPLANTED, THE PATIENT EXPERIENCED BLURRY VISION OS AND WAS UNABLE TO SEE. THE DOCTOR PERFORMED A ¿LASER TREATMENT¿ (UNKNOWN DATE), WHICH DID NOT WORK. THE PATIENT HAD LIMBAL RELAXING INCISION PROCEDURE DONE ON OS ON (B)(6) 2022. THE PATIENT WAS PRESCRIBED ¿ANTIBIOTIC¿ EYE DROPS AFTER THE MOST RECENT PROCEDURE (UNKNOWN NAME, DOSAGE, OR FREQUENCY), AND RECENTLY RAN OUT OF DROPS. THE PATIENT STATED THAT OS FEELS SCRATCHY, AS IF THERE WAS SAND IN THE EYE. THE PATIENT SAID THE ¿ANTIBIOTIC¿ EYE DROPS WERE MAKING OS FEEL SO MUCH BETTER, BUT ALSO CAUSING THE EYE TO BE BLURRY FOR A LONG TIME AFTER USING IT. HOWEVER, ONCE THE DROPS ¿ABSORBED¿ THE PATIENT WAS THEN ABLE TO SEE A LITTLE C

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye

  MAUDE report 16400774 ↗
• InjuryDec 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (OS), LEFT EYE. ACCOUNT INDICATED THAT ON (B)(6) 2020 THE PATIENT HAD A PARS PLANA VITRECTOMY TO REMOVE FLOATERS FROM OS. PATIENT DID NOT HAVE A HISTORY OF FLOATERS AND THE FLOATERS APPEARED AFTER IOL IMPLANTATION. IT WAS ALSO REPORTED THAT THE LEFT EYE IOL HAD BECOME DISPLACED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 13115238 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SIGNIFICANT VISION PROBLEMS AND POOR VISION WITH INTRAOCULAR LENS (IOL). THE PATIENT REPORTED SHE HAD MULTIPLE SURGERIES AFTERWARDS TO TRY AND CORRECT THE PROBLEMS, BUT TO NO AVAIL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT'S NIGHT DISTANCE IS BAD, ON-COMING HEADLIGHTS ARE OUT OF FOCUS, AND PATIENT COMPLAINED OF DRY EYES WHICH SHE DID NOT HAVE PRIOR TO SURGERY. THE PATIENT HAS BEEN USING OVER-THE-COUNTER (OTC) EYE DROPS TO RELIEVE THE DRY EYES. THE PATIENT HAD A YTTRIUM ALUMINUM GARNET (YAG) PERFORMED IN BOTH EYES (OU) SOMETIME IN 2016 AFTER HER IMPLANTS, HOWEVER, IT DID NOT HELP WITH HER VISUAL ISSUES. LASIK WAS PERFORMED IN THE LEFT EYE ONLY WHICH ALSO DID NOT HELP WITH HER VISUAL ISSUES. THE PATIENT ALSO TRIED HARD CONTACT LENSES (CL) WHICH WERE NO HELP. THE LENSES REMAIN IMPLANTED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. 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: Blurred Vision; Dry Eye(s)

  MAUDE report 12801457 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. FOLLOWING HIS SURGERY, THE PATIENT WAS NOT CORRECTIBLE TO BETTER THAN ABOUT 20/50 AND VERY DISAPPOINTED. THEREFORE, THE DOCTOR DID A LENS EXCHANGE TO A MONOFOCAL LENS. ON DAY ONE AFTER THE LENS EXCHANGE, THE PATIENT WAS ALREADY 20/20 AND VERY HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 12643735 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DISSATISFIED WITH AN INTRAOCULAR LENS (IOL) AND WAS SCHEDULED TO EXPLANT THE LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT WAS COMPLAINING OF NOT BE ABLE TO READ ON THE COMPUTER. THE VISUAL SYMPTOMS WERE SIGNIFICANTLY INTERFERING WITH NORMAL DAILY ACTIVITIES. VISION ACUITY IN LEFT EYE 20/30, RIGHT EYE 20/40, AND NEAR VISION IN OU 20/30. THE LENS WAS PLANNED FOR AN EXPLANT, HOWEVER, FURTHER INFORMATION WAS RECEIVED REPORTING THE PLANNED EXPLANT HAS BEEN CANCELLED. THE LENS REMAINS IMPLANTED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 10310683 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZLB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE ZLB00 21.5 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO GOAL OF PLANO WAS NOT MET, RESULT WAS +1.00 WITH COMPLAINTS OF GLARE AND HALOS. THE PATIENT WAS NOT ABLE TO TOLERATE, AND OUTCOME SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THE ZLB00 21.5 DIOPTER LENS WAS REPLACED WITH A MODEL ZA9003 22.5 DIOPTER LENS. IT WAS REPORTED THE PATIENT HAS RECOVERED AND NO FURTHER INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 9690191 ↗
• InjuryJan 7, 2020Adverse 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 PATIENT'S LEFT EYE DUE TO PATIENT COMPLAINT OF VISION NOT BEING CLEAR, GLARE AT NIGHT AND VISUAL DISTURBANCE. THERE WAS NO PATIENT INJURY BUT A LIMBAL RELAXATION INCISION WAS PERFORMED. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT OUTCOME WAS EXCELLENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 9560276 ↗
• InjuryOct 15, 2019Adverse 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 OPERATIVE EYE DUE TO A POWER MISS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9193509 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT IS NOT HAPPY WITH THE REFRACTIVE OUTCOME. THERE IS NO INDICATION OF INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE REQUIRED. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9148293 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO HYPEROPTIC MISS. THE PATIENT THOUGHT THAT IT WOULD GO AWAY, BUT DID NOT. THE REPLACEMENT WAS A ZXR00, 22.0 DIOPTER POWER. IT WAS LEARNT THAT THE PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8955049 ↗
• MalfunctionJun 11, 2019Contamination; Contamination

  IT WAS REPORTED A SPECK WAS OBSERVED ON A ZLB00 INTRAOCULAR LENS (IOL) DURING PRODUCT HANDLING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8685693 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS BILATERAL IMPLANTS; HOWEVER, HE HAS BEEN ABLE TO SEE WELL IN HIS RIGHT EYE FOLLOWING SURGERY BUT NOT IN HIS LEFT EYE DESPITE REFRACTION. RETINAL SCANS APPEARED TO BE NORMAL, HOWEVER THE PATIENT COULD NOT READ CLEARLY, AND HIS DISTANCE IS BLURRY AS WELL. THERE IS NO EASILY IDENTIFIABLE FACTOR CONTRIBUTING TO THIS. REPORTEDLY, A ZLB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 AND REPLACED WITH ANOTHER ZLB00 WITH A HIGHER 22.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8676036 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME TOO HYPEROPIC POST-OPERATIVE. THE PATIENT WAS DISAPPOINTED SHE COULD NOT READ. IN THE FIRST WEEK, THE PATIENT'S VISION WAS 20/25, J12. AT THE THIRD WEEK VISION ACUITY WAS 20/50. REFRACTION SPHERICAL EQUIVALENT (SE) +0.75D. IT WAS STATED, MOST LIKELY THE ELP (ESTIMATED LENS POSITION) SHIFTED POSTERIORLY AS THE CAPSULE CONTRACTED. THE DOCTOR PLANNED ON EXPLANTING THE LENS FROM THE LEFT EYE AND REPLACING IT WITH ANOTHER ZLB00 OF A HIGHER DIOPTER 22.5. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8614497 ↗
• InjuryApr 8, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZLB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT NEEDED A DIFFERENT LENS POWER (DIOPTER). THE SURGEON ALSO NOTICED THAT THE LENS HAD SHIFTED DURING POST-OP EXAMINATION. THERE WAS NO INCISION ENLARGEMENT OR SUTURE USED. THE REPLACEMENT LENS WAS A ZLB00 23.0 DIOPTER. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8490279 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) HAD TO BE REMOVED FROM THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2019 DUE TO AN UNSPECIFIED EYE ISSUE. INCISION WAS ENLARGED, BUT NO INJURY TO THE PATIENT. A REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS, SAME DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8383953 ↗
• MalfunctionFeb 4, 2019Break; Break

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS OBSERVED TO HAVE A HAPTIC DAMAGED WHEN REMOVING FROM THE PACKAGING. THERE WAS NO PATIENT CONTACT WITH THE IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8303634 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL ZLB00 INTRAOCULAR LENS IMPLANTS. THE PATIENT REPORTED THAT SHE WAS TOLD THAT SHE WOULD NOT NEED GLASSES AFTER THE PROCEDURE HOWEVER SHE STILL NEEDS GLASSES FOR BOTH FAR AND CLOSE VISION. THE PATIENT ALSO REPORTS THAT SHE SEES MANY RINGS AROUND LIGHTS AT NIGHT, AND IT IS EXTREMELY DIFFICULT DRIVING AT NIGHT. NO OTHER INFORMATION WAS PROVIDED. 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: Halo; No Code Available; Visual Disturbances

  MAUDE report 8287941 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 21.5D INTRAOCULAR LENS (IOL) WILL BE REMOVED (EXPLANTED) AND REPLACED FROM THE LEFT EYE DUE TO SUB-OPTIMAL ACUITY (+1.50 AND J3). THE RIGHT EYE (OD) HAS A SYMFONY IOL AND IS DOING VERY WELL. ADDITIONAL INFORMATION INDICATED THE PATIENT COMPLAINS OF FOGGY/BLURRY VISION AND GLARE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8282052 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZLB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) BROKE OFF IN THE CARTRIDGE AND WASN''T NOTICED UNTIL INSERTING INTO THE PATIENT''S OPERATIVE EYE. THEREFORE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS, SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270140 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2018 INTO THE PATIENT¿S RIGHT EYE AND EXPLANTED ON (B)(6) 2018 DUE TO MECHANICAL FAILURE. AT EXPLANT THERE WAS A NEW INCISION MADE, BUT NO VITRECTOMY OR SUTURES REQUIRED. THE LENS WAS REMOVED IN TWO PIECES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8251672 ↗
• InjuryJan 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED TO REPORT HE HAS BLURRY VISION, HE CAN'T READ ANYTHING, WHEN WATCHING TV HE CAN TELL IT'S A PERSON; HOWEVER, HE CAN NOT SEE THE DETAILS OF THEIR FACE. IT HAS BEEN LIKE THIS FOR OVER A YEAR. HE STATES HE HAD HAD SEVERAL APPOINTMENTS WITH HIS DOCTOR AND THE DOCTOR ONLY OFFERED A FREE PAIR OF GLASSES AND A (B)(6) DOLLARS. IN FOLLOW UP CONVERSATION WITH THE PATIENT, HE REPORTED THAT RIGHT AFTER IMPLANT OF HIS INTRAOCULAR LENSES, HE WAS NOT SEEING WELL. HE RETURNED TO HIS DOCTOR WHO PERFORMED, WHAT HE THINKS WERE YAG LASER PROCEDURES, ON BOTH HIS EYES. HE WASN'T EXACTLY SURE OF THE PROCEDURE NAME. THE PATIENT STARTED GETTING FLOATERS REALLY BAD AFTER THAT. HE WAS NOT TREATED SPECIFICALLY WITH ANY TYPE OF MEDICATION FOR THE FLOATERS. THE PATIENT STATED HE THINKS HE HAD LASER TWICE. ONCE IN THE OFFICE IN (B)(6) AND THEN ANOTHER TIME IN THE DOCTOR¿S OFFICE, (B)(6). SECOND TIME WASN'T LASER, BECAUSE THE LASER EQUIPMENT WAS NOT AVAILABLE. THE PATIENT STATED THE DOCTOR SCRAPED HIS EYE, HE THINKS, BECAUSE HIS EYE HAD A LITTLE BLOOD AFTERWARDS. HE HAS ALSO DEVELOPED DRY EYES SINCE SURGERY, (DID NOT HAVE BEFORE SURGERY). PATIENT TAKES EYE VITAMINS, AND USES OVER THE COUNTER DR

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 8220606 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED TO REPORT HE HAS BLURRY VISION, HE CAN'T READ ANYTHING, WHEN WATCHING TV HE CAN TELL IT'S A PERSON; HOWEVER, HE CAN NOT SEE THE DETAILS OF THEIR FACE. IT HAS BEEN LIKE THIS FOR OVER A YEAR. HE STATES HE HAD SEVERAL APPOINTMENTS WITH HIS DOCTOR AND THE DOCTOR ONLY OFFERED A FREE PAIR OF GLASSES AND A COUPLE HUNDRED DOLLARS. IN FOLLOW UP CONVERSATION WITH THE PATIENT, HE REPORTED THAT RIGHT AFTER IMPLANT OF HIS INTRAOCULAR LENSES, HE WAS NOT SEEING WELL. HE RETURNED TO HIS DOCTOR WHO PERFORMED, WHAT HE THINKS WERE YAG LASER PROCEDURES, ON BOTH HIS EYES. HE WASN'T EXACTLY SURE OF THE PROCEDURE NAME. THE PATIENT STARTED GETTING FLOATERS REALLY BAD AFTER THAT. HE WAS NOT TREATED SPECIFICALLY WITH ANY TYPE OF MEDICATION FOR THE FLOATERS. THE PATIENT STATED HE THINKS HE HAD LASER TWICE. ONCE IN THE OFFICE IN (B)(6) AND THEN ANOTHER TIME IN THE DOCTOR¿S OFFICE, (B)(6). SECOND TIME WASN'T LASER, BECAUSE THE LASER EQUIPMENT WAS NOT AVAILABLE. THE PATIENT STATED THE DOCTOR SCRAPED HIS EYE, HE THINKS, BECAUSE HIS EYE HAD A LITTLE BLOOD AFTERWARDS. HE HAS ALSO DEVELOPED DRY EYES SINCE SURGERY, (DID NOT HAVE BEFORE SURGERY). PATIENT TAKES EYE VITAMINS, AND USES OVER THE COUNTE

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 8220449 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO VISUAL DISTURBANCE. REPORTEDLY, THE PATIENT''S SYMPTOMS STARTED ON POST OP DAY ONE. THERE WAS NO SURGICAL INTERVENTION REQUIRED AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7982290 ↗