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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided gender/sex: unknown, information not provided if implanted, if explanted, give date: not applicable as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Received report that a zma00, 20.0 diopter lens was inserted in the patient¿s operative eye.The patient¿s anatomy would not hold the iol.The lens was removed, and no replacement lens was implanted.A vitrectomy was performed.Reportedly the patient is doing well.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, yes.Returned to manufacturer on, 08/28/2019.Device returned to manufacturer: yes.Device evaluation: the product was received in a lens case.Visual inspection with the unaided eye shows the product is damaged, most probably to make the explant possible.The product is inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that both loops are damaged and the optic body is torn as well as the edge is damaged.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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
• 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: 8931552
• Report Number: 9614546-2019-00776
• Device Sequence Number: 13525618
• Product Code: MFK
• UDI-Device Identifier: 05050474536807
• UDI-Public: (01)05050474536807(17)220905
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 09/05/2022
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/30/2019; 10/25/2020
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/25/2019; 11/11/2020
• 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
• Date Report Sent to FDA: 01/01/2005