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

Model Number	Z9002
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, remains implanted in the eye.Device evaluation: product testing could not be performed because the product was not returned.As it is still implanted.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no other complaints have been received for this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that on (b)(6) 2019, patient had milky white lenses in both operative eyes.There were no laser marks.On (b)(6) 2008 patient had tecnis lens implanted in right (od) eye and on (b)(6 )2008 had tecnis lens implanted in left (os) eye.Last eye exam was performed 2 years ago, and physician said nothing had changed at that time.Yag capsulotomy was performed on both eyes.Patient outcome was reported as 20/50 (right eye) 20/200(left eye).This report will capture the event for the patient¿s right eye.A separate report is being submitted for the patient¿s left eye.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-(b)(4) 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: 9351938
• Report Number: 2648035-2019-01228
• Device Sequence Number: 2242899
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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: 11/30/2012
• Device Model Number: Z9002
• Device Catalogue Number: Z900200190
• 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: 10/23/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/05/2020
• 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: Other
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005