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

Model Number	ZMA00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, the lens remains implanted.Device evaluation: the product was not returned to the manufacturing site as it is 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.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no similar complaints were received for this production order number.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 he had a multifocal lens inserted in his right (od) eye first (unknown manufacturer).After 2 weeks, he rubbed his eye and caused the lens to rotate.The surgeon attempted to reposition it a few times but was not successful.The surgeon then replaced the original lens with this lens (zma) on (b)(6) 2019.Patient said that two days post-op, he started to see double.It seemed that it was always at the left lower corner where the images became most blurry.He visited the surgeon about a week ago ((b)(6) 2019) and complained that his vision has not improved.The surgeon tried to adjust the lens, but it would not center.The surgeon asked that the patient to give it some time to adjust.The surgeon also indicated a monofocal anterior lens may work if the patient requires a lens exchange.No further information 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.
Additional Manufacturer Narrative
Additional info: based on receiving new information, additional patient code 3191 has been entered into section h6.Further information was provided by the patient that the zma00 intraocular lens (iol) has been explanted by a different doctor and that his symptoms are gone.He is doing great and is happy with the last surgical outcome.Section h6: patient code: 3191 - explant.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8580800
• Report Number: 9614546-2019-00420
• Device Sequence Number: 19216526
• Product Code: POE
• UDI-Device Identifier: 05050474536722
• UDI-Public: (01)05050474536722(17)200401
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P080010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0160
• 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: 04/05/2019
• Supplement Date Received by Manufacturer: 08/05/2020; 10/25/2020
• Initial Report FDA Received Date: 05/04/2019
• Supplement Report FDA Received Date: 08/28/2020; 11/12/2020
• 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: 47 YR
• Date Report Sent to FDA: 01/01/2005