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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If explanted; give date: two (2) explant dates were provided, but did not specify patient's eye.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Reportedly, the physician performed cataract surgery on (b)(6) 2017 on patient's eye.The physician implanted symfony toric multifocal lenses.After the initial surgery, patient did experience glaring halos and was unable to drive a car.Prior to surgery, patient was not aware that these symptoms would occur.Consequently, other physician explanted her multifocal lenses on (b)(6) 2017.The physician implanted patient's right eye (od) due to a stigmatism, while the other left eye (os) was implanted with standard lens.Per follow-up, the patient did not recall which eye was explanted first and stated that the problems started immediately, but could not provide an exact date.The patient mentioned her symptoms to the doctor.And she was advised to wait for her eyes to adapt.Patient was also prescribed glasses by her doctor, but didn¿t help.Moreover, the symptoms were so bad that they affect her ability to drive.It was stated that there was no patient injury however.No additional information provided.This report pertains to left eye (os).A separate report has been submitted to right eye (od).
Additional Manufacturer Narrative
Based on new information received on july 30, 2018, the following sections have been updated accordingly: if explanted; give date: two (2) explant dates were provided, (b)(6) and (b)(6) due to severe glare, but did not specify which eyes.Additional patient code 3191 - glare.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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7656176
• Report Number: 9614546-2018-00629
• Device Sequence Number: 19210434
• Product Code: MFK
• UDI-Device Identifier: 05050474605893
• UDI-Public: (01)05050474605893(17)211108
• Combination Product (Y/N): Y
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018
• 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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/08/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U250
• 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: 06/04/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 08/27/2018
• 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