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

Model Number	ZXT150
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted and therefore not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgery center reported that when they opened the zxt150 22.0 diopter intraocular lens (iol) container and flipped the door, a very small piece of plastic was observed by the technician on the lens.It looked like the plastic was a part of something that should not be on the lens.Therefore, the center did not use the lens and it never made it to the cartridge.They used the back-up lens instead and the surgery went well.No other information was provided.
Additional Manufacturer Narrative
Based on new information from product testing, the following section has been updated accordingly: device evaluation; investigation results were updated to further address that there is no piece of plastic observed on the lens.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 8/24/2018.Device returned to manufacturer? yes.Device evaluation: the product was received in a lens box.The sample was inspected by a qualified final inspection operator using 12x magnification.It can be seen that the lens is contaminated.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.The condition of the return sample does not suggest the issue occurred during manufacturing.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: 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: 7635964
• Report Number: 9614546-2018-00606
• Device Sequence Number: 16693083
• Product Code: POE
• UDI-Device Identifier: 05050474605244
• UDI-Public: (01)05050474605244(17)220511
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/11/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 09/25/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/20/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE, LOT# UNKNOWN
• Date Report Sent to FDA: 01/01/2005