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 Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the lens was inserted into the patient's right eye, two large scratches were observed across the optic.The lens was then removed and replaced with another lens of the same model and diopter without incident.There was no patient injury and no surgical or medical intervention required.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation ¿ yes, returned to manufacturer on 5/2/2018.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection with the unaided eyes shows the product is cut in half, most probably to make remove and replacement possible.Considering the condition of the lens additional analysis is not possible.The customer's reported complaint could not be verified.Manufacturing records review: 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.Labeling review: 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: 7482157
• Report Number: 3011852734-2018-00070
• Device Sequence Number: 1630463
• Product Code: MFK
• UDI-Device Identifier: 05050474560666
• UDI-Public: (01)05050474560666(17)210507
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 05/07/2021
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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: CARTRIDGE MODEL 1MTEC30; CARTRIDGE MODEL 1MTEC30
• Patient Age: 71 YR