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

Model Number	ZCT225
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.  (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor is considering explanting the tecnis toric intraocular lens (iol) implanted in the patient¿s right eye and the tecnis monofocal implanted in the left eye.The patient was complaining of debilitating flickering from fluorescent lights in both the eyes.Doctor did yag (yttrium-aluminum-garnet laser) procedure for some significant pco (posterior capsular opacification) in the left eye, but this did not help.Doctor had to reposition the toric iol once and it rotated again second time.The patient is post laser vision correction in both eyes years ago.Patient did not have any such dysphotopsias until after iol implantation.Additional information was received for right eye and it was learnt that the patient has trouble with fluorescent lighting blinking, it¿s sometimes is better when patient puts glasses on.Patient has also noticed that problems have started with glare especially at night.Explant has not yet been performed.This report will cover information related to the right eye.A separate report will be submitted for the left eye.No further information provided.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7524739
• Report Number: 9614546-2018-00480
• Device Sequence Number: 19298452
• Product Code: HQL
• UDI-Device Identifier: 05050474552784
• UDI-Public: (01)05050474552784(17)210227
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018
• 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: Physician
• Device Expiration Date: 02/27/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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