MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product was returned to the manufacturing site wrapped in medical dressing placed inside a biohazard resealable bag.A visual inspection with the unaided eye revealed the lens was returned in one piece with lint fibers on surface.Lens was cleaned with purified water and dried with compressed air to ease inspection.Further inspection under 12x magnification revealed fiber and residue remains visible on iol surface.Scratches and abrasions were visible on lens surface.None of these cosmetic issues will impact the mechanical behavior of the lens.The complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zlb00 intraocular lens (iol) was implanted in the patient's right (od) eye on (b)(6) 2018.It was later explanted on (b)(6) 2019 due to mechanical failure.At 1 week postop, patient reported symptoms of cloudy, fuzzy, blurred vision at distance and near, and glare with night driving.A refraction was performed and the symptoms could not be resolved with prescription lenses.The patient was not adapting to the multifocal implant.Pre-ops best corrected visual acuity (bcva) was 20/40 at distance and j2 at near, bat glare testing 20/400.Post-ops bcva is 20/30 distance vision and j1 near vision.Reportedly, the patient's vision is great now.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review of the file the initial report was inadvertently submitted under an incorrect manufacturer report number.The report number provided in section g9 of the initial mdr should have begun with 2020664.Section g9: manufacturer report number should begin with 2020664.Note: the device was manufactured at the kulim site which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9785078
• Report Number: 9614546-2020-00098
• Device Sequence Number: 13622910
• Product Code: MFK
• UDI-Device Identifier: 05050474560598
• UDI-Public: (01)05050474560598(17)220909
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/05/2020; 10/25/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/17/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005