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

Model Number	ZCB00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Visual Impairment (2138); 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) 2018 and (b)(6) 2018.(b)(4).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 a zcb00 16.0 diopter intraocular lens (iol) was implanted in the patient's operative eye on (b)(6) 2018.It was later explanted on (b)(6) 2018 due to visual issues.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was the same model, but different diopter of 18.0.Reportedly, the patient is doing fine.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation.Returned to manufacturer on: 01/16/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was not returned complete because pieces were missing.The lens was cut most probably to facilitate the explant mentioned on the initial report.Further analysis is not possible due to the conditions of the lens.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & 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 (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: 8210972
• Report Number: 2648035-2019-00004
• Device Sequence Number: 16551900
• Product Code: HQL
• UDI-Device Identifier: 05050474531635
• UDI-Public: (01)05050474531635(17)220203
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 02/03/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 10/25/2020
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/24/2019; 11/06/2020
• 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