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

Model Number	ZCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: exact date is unknown/not provided, best estimate is during (b)(6)2020.Phone number: (b)(6).(b)(4).Device evaluation: a product testing could not be performed as the product was not returned for evaluation (the device was discarded by the customer).Therefore, the reported issues could not be verified, and a product quality deficiency could not be identified.Manufacturing record review: the manufacturing process record was evaluated and there was no nonconformance related to this production order.The review found no deviation during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: 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 after an intraocular lens (iol) was implanted in the patient's eye, substances were found on the backside of the lens surface which could not be sucked out.This issue affected the patient's post operative vision.Reportedly, the lens was explanted in a secondary surgical procedure.It was noted that the product and foreign material were not kept by the doctor and were disposed.No further information has been 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: 10242429
• Report Number: 2648035-2020-00476
• Device Sequence Number: 2679454
• Product Code: HQL
• UDI-Device Identifier: 05050474531611
• UDI-Public: (01)05050474531611(17)231024
• Combination Product (Y/N): Y
• Initial Reporter Country: CN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000150
• 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: 06/09/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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