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

Model Number ZA9003

Device Problem Break (1069)

Patient Problems Vitrectomy (2643); No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted, if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after an intraocular lens (iol) was fully inserted into the patient's eye, the surgeon noticed that the haptic was broken.The lens was removed and replaced using a back-up iol of the same model and diopter.It was stated that the incision was enlarged, required one stitch, and a vitrectomy was performed.There was no patient post-op injury.No other information was provided.

Manufacturer Narrative

Additional information: device available for evaluation? yes.Returned to manufacturer on: 7/15/2020.Device returned to manufacturer? yes.Device evaluation: a packaging box of za9003 was received with a lens inside the lens case.The lens was observed under microscope (10x) and it was observed with residues in the optic zone.One of the haptic was observed positioned and without damages and the other was observed bent.The complaint was verified however it could be related to the handling process.A product quality deficiency was not identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that 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
• 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: 10299095
• MDR Text Key: 199993903
• Report Number: 2648035-2020-00518
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474528925
• UDI-Public: (01)05050474528925(17)211122
• Combination Product (y/n): Y
• PMA/PMN Number: P990080
• 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

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• 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
• Treatment: EMERALDC30 CARTRIDGE
• Patient Outcome(s): Required Intervention