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)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/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 an intraocular lens (iol) was explanted from the patient's operative eye due to anisometropia.There was no indication of patient injury or that medical or surgical intervention was required.The patient has recovered.No further information is available.
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.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation?: yes.Returned to manufacturer on: 8/26/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the lens was evaluated under microscope and was observed cut with a haptic detached and have residues of viscoelastic.The condition observed is consistent with a lens that has been explanted.There is no specific issue reported however, lens cut and haptic detached was confirmed but it could not be determined if the condition observed is related to manufacturing process as the reported lens was handling and used in a surgical procedure.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.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.

• 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: 10423239
• Report Number: 2648035-2020-00626
• Device Sequence Number: 2942729
• Product Code: HQL
• UDI-Device Identifier: 05050474530799
• UDI-Public: (01)05050474530799(17)240611
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 06/11/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 10/25/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/02/2020; 10/29/2020
• 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