MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted or explanted, give date: not applicable, as the lens was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zlb00 16.0 diopter intraocular lens (iol) was noticed scratched when removing from packaging with no patient contact.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 04/24/2018.Device returned to manufacturer: yes.The product was returned to the manufacturing site for evaluation.Visual inspection shows the product was cut into a few pieces, and only two pieces were returned for investigation.The returned parts do not form a complete product.The lens was inspected by a qualified final inspection manufacturing specialist using 12x magnification.Scratches marks were observed in the middle of the lens near to the cutting area.Unable to determine if these scratches were a result from lens cutting process or handling process.Cosmetic issue is confirmed however how and when the scratches were introduced could not be determined.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7464399
• Report Number: 3011852734-2018-00065
• Device Sequence Number: 11148684
• Product Code: MFK
• UDI-Device Identifier: 05050474560598
• UDI-Public: (01)05050474560598(17)210717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/16/2018

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: 07/17/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1