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

Model Number	ZXR00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens was implanted in the patient's left eye on (b)(6) 2018 and explanted on (b)(6) 2018 due to a mechanical failure.Additional information received indicated that there was no patient injury, no suture(s), no vitrectomy, the incision was enlarged, and the doctor used the same incision to remove the lens in one piece.Through follow up, the customer account provided additional information stating the reported mechanical failure symptoms were initially reported by the patient and first observed on (b)(6) 2018, blurry vision with all activities especially when driving.The patient was instructed to use artificial tears on a set schedule to see if visual symptoms were related to dryness.Further evaluation was performed on 11-apr-2018, the patient reported no resolution of visual symptoms with the artificial tear use.The mechanical failure symptoms of continued blurry vision and ghosting of images with shadows around images, especially with driving, were not resolved with spectacle correction.The explanted lens was replaced with an model aab00 16.5 diopter lens.Patient outcome post-lens exchange was good as reported by the patient, and reported mechanical failure symptoms have been resolved.No additional information was provided to johnson and johnson surgical vision, inc.
Additional Manufacturer Narrative
Corrected data: in review of the file, it was noted that the initial mdr returned to manufacturer had an incorrect date entered.The following has been updated accordingly: returned to manufacturer: 07/10/2018.Device evaluation: the product was received in a zip lock bag.The sample was inspected by a qualified final inspection operator using 12x magnification.It can be seen that the lens is a little grey on the edge of the optic.It could be contamination.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmentally controlled area.The 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: as a result of the investigation there is no indication of a product quality deficiency or product malfunction and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7585587
• Report Number: 9614546-2018-00559
• Device Sequence Number: 13864434
• Product Code: POE
• UDI-Device Identifier: 05050474579019
• UDI-Public: (01)05050474579019(17)221027
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018
• 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: 10/27/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005