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 Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event, exact date unknown/not provided.Best estimate date is between (b)(6) 2019.(b)(4).An attempt has been made to obtain missing information; however, no definitive 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 patient was myopic post-operative in the left eye.The intraocular lens (iol) was therefore explanted.The replacement lens was a same model, but a lower diopter.The patient is doing as expected.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 12/12/2019.Device evaluation: the lens is torn and missing pieces; most probably related to the reported lens explant.The customer in the initial report identified the issue as relating to a specific visual issue (myopia).The customer did not select product issue as reason for explant/removal and replacement.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no additional investigation request (ir) for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Further information was provided and reported patient had visual disturbance.At 1-day post-operative, the patient was 20/20.A few days after that, the patient's vision started getting blurry.By week 1, the patient was -1 and by week 3 the patient was -1.5.There was no incision enlargement or unplanned sutures when the lens was removed.At the 1 month visit, the patient was plano 20/20 in the left eye.No additional information was provided.The following sections have been updated accordingly: (b)(4).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-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: 9466509
• Report Number: 2648035-2019-01325
• Device Sequence Number: 13911968
• Product Code: HQL
• UDI-Device Identifier: 05050474531932
• UDI-Public: (01)05050474531932(17)211104
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 11/04/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 01/23/2020; 10/25/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/09/2020; 02/19/2020; 11/04/2020
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005