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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between.Email address unknown, information not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the za9003 intraocular lens (iol) was explanted from the patients right eye due to astigmatism.The goal was to achieve plano but resulted in -0.37.The explanted iol was replaced with a toric lens.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 08/23/2019.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.The lens was received cut in two pieces.There is a portion of the lens missing.This could be related to the explant of the lens.Due to condition of the returned lens, no further evaluation is possible.The reported issue could not be verified.There is no indication of a product quality deficiency.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints have been received for this production order number.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 (b)(4) and capa(b)(4).

• 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: 8949940
• Report Number: 2648035-2019-00932
• Device Sequence Number: 19619818
• Product Code: HQL
• UDI-Device Identifier: 05050474529137
• UDI-Public: (01)05050474529137(17)210419
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• 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: 04/19/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 10/25/2020
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/27/2019; 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