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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: unknown, not provided.If explanted, give date: not applicable as there is no indication that the lens was explanted.(b)(6).It was indicated that the device is not returning for evaluation as to date it remains implanted; 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.Toxic anterior segment syndrome (tass).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that following the implantation of the intraocular lens (model zcb00 +13.5 diopter), the patient developed toxic anterior segment syndrome (tass).Reportedly, treatment for tass was administered accordingly.The lens remains implanted.No further 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 92705
• MDR Report Key: 7713319
• Report Number: 2648035-2018-01036
• Device Sequence Number: 1753942
• Product Code: HQL
• UDI-Device Identifier: 05050474531581
• UDI-Public: (01)05050474531581(17)210811
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 08/11/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000135
• 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: 06/27/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/24/2018
• 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: 76 YR
• Date Report Sent to FDA: 01/01/2005