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	Vitrectomy (2643)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.It was indicated that the device is not returning for evaluation as it was discarded by the customer; therefore a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcb00 12.5 diopter intraocular lens was inserted and then removed due to issues with the patient's eye requiring a vitrectomy to be performed.The account commented that there were no issues with the lens.Reportedly, the lens was discarded by the account.No additional information was provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information 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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7741843
• Report Number: 2648035-2018-01078
• Device Sequence Number: 11398411
• Product Code: HQL
• UDI-Device Identifier: 05050474531567
• UDI-Public: (01)05050474531567(17)211010
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020
• 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: 10/10/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000125
• 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: 07/10/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 11/02/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005