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

Model Number	Z9002
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted; give date: unknown/not provided.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had a difficulty seeing in her right eye due to foreign material or debris on the rear surface of implanted lens model, z9002 monofocal iol (intraocular lens).The doctor attempted to peel this debris off by using yag (yttrium-aluminum-garnet) laser on (b)(6) 2018, but it was reportedly impossible.As a result, lens was explanted and replaced instead.No additional information provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 03/25/2019.Device evaluation: the sample was received in a tube (with liquid) at the manufacturing site for evaluation.The lens was observed cut.The (2) haptics were observed: one in good conditions and the other haptic was overserved distorted.No particles were observed.Post market surveillance officer evaluated the images (dvd) provided by the customer and determined: a definitive conclusion cannot be made from the provided images.The 4 provided dark fields were evaluated under the slit lamp and the pictures show the anterior segment of an apparently pseudophakic eye (implanted iol model cannot be determined from the picture assessment).An amorphous/granular material causing the lens opacification apparently located in all the visible anterior surface of the observed intraocular lens.It is not possible to make a conclusive determination regarding the potential nature/origin of the issue from the picture assessment of the provided images.Manufacturing records review: the manufacturing records for the product was reviewed.No deviation was found during process related to the complaint issue.There are no discrepancies found during the mrr (manufacturing record review).The product was manufactured and released according to specification.A search in complaint history revealed no additional investigation request for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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: 8427193
• Report Number: 2648035-2019-00344
• Device Sequence Number: 2170466
• Product Code: HQL
• UDI-Device Identifier: 05050474530713
• UDI-Public: (01)05050474530713
• Combination Product (Y/N): Y
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 02/28/2013
• Device Model Number: Z9002
• Device Catalogue Number: Z900200210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/24/2019; 10/25/2020
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 05/21/2019; 11/11/2020
• 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