MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens remains implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that doctor had hard time pushing the injector of tecnis itec preloaded 1-piece intraocular lens (iol) device and the injector tip looks a frayed at the end.The lens was delivered into patient's eye and the patient is doing fine.No patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on 4/11/2018.Device evaluation: the preloaded intraocular lens (iol) was returned to the manufacturing site for evaluation.The cartridge component was observed correctly engaged into lower body of the pcb00 device.Some traces of viscoelastics and / or body fluids related to the eye are observed only at the tip of the cartridge; directions for use include to completely fill the viewing window with ovd.The cartridge is observed cracked the tip is deformed due to the crack; the reported issue was verified.The plunger component was observed in advanced position.No assembly defects are observed on the device.Visual inspection with microscope magnification was performed.Based on the visual evaluation of the returned unit, it could not be determined that the cause of the issue reported is related to the manufacturing process.No product quality deficiency was identified.The customer's reported complaint was 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 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 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 was verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7435339
• Report Number: 2648035-2018-00534
• Device Sequence Number: 19261643
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)200822
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• 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: 08/22/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1