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

Model Number	Z9002
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 (b)(6) 2019.(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that tecnis monofocal intraocular lens (model z9002 +16.5 diopter) was explanted from patient¿s right eye because of patient experiencing residual refractive error.There was no incision enlargement, no sutures and no vitrectomy required.Lens with same model and higher diopter of +18.0 was used as replacement for the patient.Patient was doing well.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 9/27/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was observed under microscope and it was observed with one of the haptics bent and the other positioned.The lens was received cut in two pieces.Customer states a residual refractive error.The directions for use (dfu), tecnis foldable silicone iols with optiedge (multilingual) provide the customers references for the lens power calculations.Due the sample condition complaint could not be verified.A product quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed no other complaint was received for this production order number.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.
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 CL
• 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: 9132148
• Report Number: 2648035-2019-01057
• Device Sequence Number: 2262479
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)220722
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 07/22/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/25/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/17/2019; 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005