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

Model Number Z9002

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

Patient Problems Inflammation (1932); Iritis (1940); Irritation (1941)

Event Date 03/22/2020

Event Type  Injury  

Manufacturer Narrative

If explanted, give date: not applicable, the lens remains implanted.(b)(4).Device evaluation: the product was not returned as it remains implanted; 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 two additional complaint folders for this production order number; however, they are 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 patient reported that after the implementation of a z9002 intraocular lens (iol) in her right (od) eye on (b)(6) 2020, she is experiencing stinging, itching and burning in her eye, that began after discontinuing medicated eyedrops prescribed by her doctor after the surgery.The irritation is causing her eyes to water excessively.She described it like being pepper sprayed.In addition, the irritation has woken her up in the night.These episodes last about 1-2 minutes, but don¿t occur every day.She said it ¿spread¿ over to the other eye, that she also had an implant in.The left eye was implanted with a non-johnson and johnson lens.Through follow up, it was learned that the patient saw her doctor on (b)(6) 2020 and was told that she has iritis and was prescribed inzeltys for the inflammation.She was instructed to use 2 times/day for 2 weeks and 1 time/day for the following 2 weeks thereafter.The inflammation has cleared up and she is no longer having issues with irritation on (b)(6) 2020.The patient is being monitored by her doctor and will have another follow up visit after the covid-19 homebound order is lifted.She does not have any other symptoms and is satisfied with the result.No further 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 CL
• 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: 9999027
• MDR Text Key: 188977750
• Report Number: 2648035-2020-00390
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530744
• UDI-Public: (01)05050474530744(17)240829
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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: 04/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Z9002
• Device Catalogue Number: Z900200225
• 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: 76 YR