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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The account provided two (2) different event dates (b)(6) 2018.If implanted, give date: unknown.The exact date was not provided but it is either (b)(6) 2018.If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.(b)(6).It was indicated that the lens remains implanted and it is not returning for evaluation; 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (model zcb00) was implanted into the patient's operative eye, the surgeon noticed a damaged spot on the optic edge.According to the account, the lens was carefully examined and loaded correctly in the cartridge, but it must have got damaged on the tightest part of the cartridge before implantation.Reportedly, the lens remains implanted.No patient injury was reported.No further 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 (b)(4).

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7673859
• Report Number: 2648035-2018-00976
• Device Sequence Number: 1528558
• Product Code: HQL
• UDI-Device Identifier: 05050474531833
• UDI-Public: (01)05050474531833(17)210517
• Combination Product (Y/N): Y
• Initial Reporter Country: SE
• 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: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000260
• 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: 06/19/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/10/2018
• 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
• Date Report Sent to FDA: 01/01/2005