MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the zcb00 intraocular lens (iol) was explanted from the patient's right eye, and replaced with another lens of the same model but lower diopter (24.5).Additional information received reported visual disturbance, unexpected post-op refraction and residual myopia in the right eye (od).An incision enlargement was performed and the patient has recovered.No additional information was reported.
Additional Manufacturer Narrative
Device evaluation: the sample was evaluated and the lens was cut.Only a half of the lens was received.The condition observed is consistent with a lens that has been explanted.The reported issue could not be verified.It could not be determine if the issue reported is related to manufacturing process as the lens was used and cut in a surgical procedure.Based on the product returned evaluation, a product quality deficiency or product malfunction could not be determined.However, the miq (measurement iol quality) report was reviewed and the lens diopter measure meet specifications.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaint has been 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 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS 1-PIECE
• 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: 8899425
• Report Number: 2648035-2019-00884
• Device Sequence Number: 10842358
• Product Code: HQL
• UDI-Device Identifier: 05050474531833
• UDI-Public: (01)05050474531833(17)211013
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 10/13/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000260
• 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: 07/23/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 10/25/2020
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/18/2019; 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