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

Model Number	ZMB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: n/a (not applicable).The lens remains implanted.(b)(4).Device evaluation: the intraocular lens (iol) remains implanted; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported post implant of a model zmb00 intraocular lens (iol) the patient experienced glare.Through follow up, it was learned the patient is still unhappy and is seeing streaks or firecrackers and glare at night.Glasses were prescribed for mild astigmatism and with anti-glare coating without much improvement in symptoms.Visual acuity pre-operative 20/40 and best corrected visual acuity (bcva) post-operative 20/30.The patient has been referred to a retina specialist for consideration of iol removal.The patient does not wish to have another surgery.At this time, the lens remains implanted.No additional information was provided.
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 (b)(4) 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: 9345204
• Report Number: 9614546-2019-01048
• Device Sequence Number: 2183661
• Product Code: MFK
• UDI-Device Identifier: 05050474535718
• UDI-Public: (01)05050474535718(17)181024
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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: 10/24/2018
• Device Model Number: ZMB00
• Device Catalogue Number: ZMB00U0245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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: Other
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005