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

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Iritis (1940); Irritation (1941)
Date of Event	03/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
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 CL
• 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: 9999027
• Report Number: 2648035-2020-00390
• Device Sequence Number: 14427128
• Product Code: HQL
• UDI-Device Identifier: 05050474530744
• UDI-Public: (01)05050474530744(17)240829
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2024
• Device Model Number: Z9002
• Device Catalogue Number: Z900200225
• 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: 04/06/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/25/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005