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

Model Number ZCB00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Gender/sex: unknown, information not provided.If implanted, if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that as the lens was being implanted into the patient¿s left eye, surgeon saw the capsule had a tear in it.Hence the lens was removed and replaced with different model lens with lower diopter of 20.0 in same surgical procedure.Incision enlargement, anterior vitrectomy was performed, and sutures were placed to close the incision.No further information provided.

Manufacturer Narrative

Additional information: device available for evaluation: yes.Returned to manufacturer on: 7/13/2020.Device returned to manufacturer: yes.Device evaluation: the product was returned.Visual inspection revealed that the lens was received covered in particles and debris, which can be attributed to the lens being returned in the lens case without being inside the inner pouch.The lens was cleaned, and no cosmetic defects were observed.The complaint issue was not confirmed, and no product deficiency was identified.Manufacturing records review: the manufacturing records for the device were reviewed.The search revealed no other complaints were received from this production order.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.

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
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10274129
• MDR Text Key: 199048335
• Report Number: 2648035-2020-00497
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531727
• UDI-Public: (01)05050474531727(17)240309
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 10/25/2020
• Supplement Dates FDA Received: 08/14/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR