MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS SYMFONY; MULTIFOCAL IOLS

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2018.(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that tecnis symfony multifocal intraocular lens (model zxr00, +24.0 diopter) was explanted from patient's left eye in secondary procedure.There was no incision enlargement, no vitrectomy.An intraocular lens from another manufacturer was used as replacement lens for the patient.Patient was doing well at discharge.No further information provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation? yes.Returned to manufacturer on: 8/1/2018.Device returned to manufacturer? yes.Device evaluation: the device was received at the manufacturing site for investigation.Visual inspection shows there was cut on the optic of the lens and the lens was dirty.The cut on the lens, most probably to make an explant possible.The lens is dirty and contaminated.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Investigation of the return sample and the condition of the return sample do not suggest the dirty and cut was introduced during manufacturing.The complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaint was received for this production order.Historical data analysis: the search in complaint history revealed no similar complaints were received for this production order number.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 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 & JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7608746
• Report Number: 9614546-2018-00588
• Device Sequence Number: 2144036
• Product Code: POE
• UDI-Device Identifier: 05050474579170
• UDI-Public: (01)05050474579170(17)211211
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018
• 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: 12/11/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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