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

Model Number	Z9002
Medical Device Problem Codes	Calcified (1077); Material Discolored (1170)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted; give date: unknown, not provided.If explanted; give date: n/a (not applicable).The lens remains implanted in the eye.(b)(6).(b)(4).Device evaluation: product testing could not be performed because the lens was not returned as it remains implanted.The reported complaint issue could not be verified.Manufacturing record review: the manufacturing records for the device were reviewed and no non-conformance reports (nc) associated to the production order were found.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaint has been received for this production order number.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 and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that something like a cloud developed on the intraocular lens (iol) implanted in the right eye of a male patient.It was indicated that the patient was treated with yag (yttrium-aluminum-garnet) laser procedure, but the symptoms are persistent.It was confirmed that the reported issue did not cause visual impairment in the patient and no patient injury was reported.Additionally, the doctor explained that the entire surface of the lens becomes white and cloudy with the z9002 which he reported the issue on it.The doctor thinks the issue is possibly calcification but he is not sure of the cause.The doctor will make the decision in (b)(6) 2020 as to whether or not the lens needs to be extracted from the patient's eye.No additional 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: 9984636
• Report Number: 2648035-2020-00369
• Device Sequence Number: 3896958
• Product Code: HQL
• UDI-Device Identifier: 05050474530683
• UDI-Public: (01)05050474530683(17)160527
• Combination Product (Y/N): Y
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2016
• Device Model Number: Z9002
• Device Catalogue Number: Z900200195
• 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: 03/27/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/22/2020
• 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: 83 YR
• Date Report Sent to FDA: 01/01/2005