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	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, not provided.Best estimate is between (b)(6) 2019 - (b)(6) 2019.The product was returned to the manufacturing site for evaluation.The lens was cut in half with residues that looks like body fluids on the lens related to the handling of the unit in a surgical procedure.The condition observed is consistent with a lens that has been explanted.The reported issue could not be verified however lens cut was confirmed but it could not be determined if the condition observed is related to manufacturing process as the reported lens was used and cut in a surgical procedure.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.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.
Event or Problem Description
It was reported that a zcb00 intraocular lens (iol) was explanted from the patient¿s right eye due to the patient experiencing visual issues, having trouble seeing traffic signs.There was nothing wrong with the iol.The lens was replaced with the same model zcb00 but a higher diopter (19.5).Reportedly, there were no complications such as vitrectomy, sutures or incision enlargement.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 nr-0148919 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: 9352659
• Report Number: 2648035-2019-01232
• Device Sequence Number: 14303516
• Product Code: HQL
• UDI-Device Identifier: 05050474531574
• UDI-Public: (01)05050474531574(17)230613
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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
• Report Date (Section B): 11/05/2020
• 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: 06/13/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/05/2020
• 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