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

Model Number	Z9002
Medical Device Problem Code	Optical Discoloration (2999)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 a z9002 intraocular lens (iol), 27.0 diopter, the doctor noticed that during post examination 60 days after surgery had become dark.It was stated that the initial post-surgical visual acuity (va) 10/10.Patient complaining of blurred vision approximately 4 months post-surgical; however, the va was 10/10.The suspect lens was explanted.There was no incision enlarged.Replacement lens was a non-jjsv iol.The patient is doing fine post-op with perfect vision.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on 1/11/2019.Device evaluation: research and development (r&d) performed an evaluation of similar issue reported and how this can affect the event.R&d chemistry wrote a technical report in which testing was done to the returned lens.As part of the results obtained from this report it was found that the lens when hydrated had a cloudy lens rating between 3 and 4.According to (b)(4), specifications for visual inspection of silicone intraocular lenses, the haze level acceptance criteria is levels 1 to 4.Therefore, no product quality deficiency was observed.This technical report (b)(4) was submitted into the agile documentation system.Manufacturing record review: the manufacturing process record was evaluated and revealed that the units were released according to product specification.Haze inspection performed in ¿slit lamp¿ operation was found within acceptable haze level.No issues were reported.A search revealed that no additional complaints were received from this production order.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.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 & 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(b)(4) and capa(b)(4).

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8136673
• Report Number: 2648035-2018-01570
• Device Sequence Number: 1333241
• Product Code: HQL
• UDI-Device Identifier: 05050474530836
• UDI-Public: (01)05050474530836(17)200226
• Combination Product (Y/N): Y
• Initial Reporter Country: AR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 02/26/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 03/28/2019; 10/25/2020
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 04/22/2019; 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005