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 Code	No Code Available (3191)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: unknown/not provided.(b)(4).Device evaluation: the lens was received wrapped in paper at the manufacturing site for evaluation.Visual inspection with the unaided eye revealed viscoelastic residue on the optic body and haptic, and that the lens was received cut in pieces (with pieces of the lens and a haptic missing), which is consistent with a lens that was handled during explant.Additionally, fibers were observed on the lens, which can be attributed to receiving the lens wrapped in paper.Based on the return condition of the lens no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency was identified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (model zcb00 5.0 diopter) was explanted from patient¿s right eye (od) in secondary surgical procedure as the patient wanted something different.Lens from another manufacturer was used as the replacement lens.No surgical and/or medical interventions such as incision enlargement, vitrectomy, or sutures were reported.There was no patient injury reported.No additional information was provided.
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 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: 9879911
• Report Number: 2648035-2020-00275
• Device Sequence Number: 11490557
• Product Code: HQL
• UDI-Device Identifier: 05050474534612
• UDI-Public: (01)05050474534612(17)210505
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: 05/05/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000050
• 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: 02/25/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005