TECNIS IOL ZLB00 (REF ZLB00U0155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474560581), received between Nov 7, 2016 and Nov 4, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED ZLB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE ZLB00 LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO REPORTED COMPLAINT OF MECHANICAL FAILURE. IT WAS REPORTED THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9273132 ↗
• InjuryJan 15, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00, +15.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF BLURRY VISION. ADDITIONAL INFORMATION REPORTS THAT AN INCORRECT LENS POWER WAS USED FOR THE PATIENT. MODEL ZMB00 +16.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7192410 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED, DATE UNKNOWN, BECAUSE OF ZONULAR DEHISENCE AT THE 2 O'CLOCK POSITION AND PRE-EXISTING ANATOMICAL ISSUES. REPORTEDLY, THE PATIENT IS STABLE WITH NO ISSUES AND ON POST OP DAY 1, LOOKS GREAT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Zonular Dehiscence

  MAUDE report 7177003 ↗
• InjuryNov 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2016. POST-OPERATIVELY, THE PATIENT REMAINS VERY DISSATISFIED WITH HIS NEAR VISION AND EXPERIENCING GLARE AND HALO. THEREFORE, AN IOL REPOSITIONING PROCEDURE WAS PERFORMED ON (B)(6) 2017 TO SEE IF THIS WOULD HELP ALLEVIATE THE PATIENT'S COMPLAINTS, BUT IT DIDN'T HELP. REPORTEDLY, EXPLANT OF THE LENS WILL BE SUBOPTIMAL FOR THE PATIENT AS HE HAS POSTERIOR VITREOUS DETACHMENTS DUE TO PATIENT ANATOMY AND A STRONG FAMILY HISTORY OF RETINAL DETACHMENTS. IT WAS ALSO REPORTED THAT THE PATIENT WAS REFERRED TO ANOTHER SURGEON WHO IS FAMILIAR WITH AMO LENSES AND IMPLANTS FOR A SECOND OPINION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Vitreous Detachment

  MAUDE report 7044316 ↗
• InjuryNov 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BILATERAL TECNIS MULTIFOCALS LENSES IMPLANTED RECENTLY. THE PATIENT IS ONE (1) MONTHS PLUS POST OP (B)(6) 2016, AND IS EXPERIENCING ADVERSE VISUAL SYMPTOMS INCLUDING CONSISTENT MOVING OR SHIFTING GLARE AND BLURRY VISION. FURTHER INFORMATION PROVIDED NOTES PATIENT WAS DOING VERY WELL (EXCLAIMED HOW CLEAR HER VISION WAS) UNTIL (B)(6) 2016 WHEN SHE DEVELOPED PVD (A FLOATER) (POSTERIOR VITREOUS DETACHMENT) IN HER OPERATIVE EYE. PATIENT NOW CANNOT TOLERATE WHAT SHE DESCRIBES AS A "SHIFTING GLARE" THAT SHE SEES ONLY WHEN SHE MOVES HER EYE. THE LENS IS PERFECTLY CENTERED AND WITHOUT PSEUDOPHAKODONESIS. SHE IS 20/25 SC (SANS CORRECTED) WITH MRX (MANIFEST REFRACTION) OF PLANO -0.50 WHICH GETS HER TO 20/20. HER OTHER EYE HAS A MODEL ZMB00 LENS AND SHE IS 20/20 SC, PLANO. DOCTOR REPORTS EVENT IS PERHAPS THE COMBINATION OF THE FLOATER AND THE OPTICS SINCE THE PROBLEM SEEMED TO COINCIDE WITH THE APPEARANCE OF THE FLOATER. HOWEVER, IT DOES NOT SEEM TO BE THE FLOATER ALONE, AS SHE DOES EXPERIENCE A MILD FORM OF THE SHIFTING GLARE IN THE RIGHT EYE, WHICH HAS A MODEL ZMB00 LENS IMPLANT. SHE CAN TOLERATE THE GLARE IN THE RIGHT EYE, BUT NOT THE LEFT. AS A RESULT THE

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6084497 ↗