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); No Code Available (3191)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device manufacture date: unknown.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation there was a problem and a capsular rupture occurred.No additional information was provided.
Additional Manufacturer Narrative
Through followup we learned that the incident took place on the (b)(6) 2019 and that the lens was in contact with the patient.A posterior capsule rupture occurred leaving the capsular bag unstable.The patient is aphakic.Pre-op visus(vision) 7/10.Another implantation is being planned.No additional information was provided.Updated fields: age/date of birth: (b)(6), sex/gender: female.Date of event: (b)(6) 2019.(b)(4).Device evaluation: material availability could not be verified after several follow-up attempts.No device evaluation could be performed.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no other complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 9583412
• Report Number: 2648035-2020-00046
• Device Sequence Number: 491883
• Product Code: HQL
• UDI-Device Identifier: 05050474529106
• UDI-Public: (01)05050474529106(17)240623
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• 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: 06/23/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030245
• 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: 12/18/2019
• Supplement Date Received by Manufacturer: 01/20/2020; 10/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/12/2020; 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: Other
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005