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 Vitrectomy (2643); No Code Available (3191)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Implant and explant date: if implanted or explanted, give date: not applicable, the lens was removed/replaced within the initial procedure.(b)(4).Device evaluation: the product was not returned; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed one additional investigation requests have been received for this production order number; however, it was not related to this complaint.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The surgeon reported that he noticed a tear in the patient's capsular bag once a zcb00 intraocular lens (iol) was inserted into the left eye.The lens was removed and replaced with a 3 piece non-johnson and johnson iol.Incision was enlarged along with vitrectomy performed.In addition, sutures were used to complete the procedure.The current patient status was reported as doing okay.The customer also indicated that the lens was not available for return.No additional information was provided.

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: 9951861
• MDR Text Key: 188143541
• Report Number: 2648035-2020-00343
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531673
• UDI-Public: (01)05050474531673(17)231214
• 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
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR