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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.If implanted, if explanted, give date: not applicable, the lens was removed/replaced within the initial procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract procedure, a capsular tear occurred resulting in a vitrectomy procedure.It was reported the surgeon made an error and realized a larger wound/incision was required.The planned za9003 intraocular lens (iol) was removed and replaced in the same procedure.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, incision enlargement was inadvertently not captured, (b)(4).Device available for evaluation; returned to manufacturer on: 8/8/2019.Device evaluation: the product was returned to the manufacturing site.The lens was received pinched in the lens case between the daisy wheel and lens case housing.The lens has a detached haptic that could be related to the removal and replacement and/or handling for return.The haptic is not mentioned as part of the issue reported.The cause of the complaint is known: handling problem.Surgeon error, needed larger wound; there is no indication of a product quality deficiency.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 additional investigation request (ir) for this production order number has been received.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.
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
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8836336
• Report Number: 2648035-2019-00784
• Device Sequence Number: 2390375
• Product Code: HQL
• UDI-Device Identifier: 05050474528864
• UDI-Public: (01)05050474528864(17)201026
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 10/26/2020
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 10/25/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/30/2019; 11/12/2020
• 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