MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during handling but prior to insertion, the cartridge tip of a preloaded delivery system (model pcb00) was noticed damaged and it had a weird shape.Additional information was received and it was learnt that there was no patient contact with the intraocular lens (iol).No patient injury was reported.The procedure was completed successfully using a backup lens with the same model and diopter size.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the preloaded delivery system (model pcb00) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the pcb00 device were reviewed.During manufacturing the operators inspect 100% all cartridges using a microscope at 10x magnification with a reticle.Operators check the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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 abbott medical optics has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6793438
• Report Number: 2648035-2017-01491
• Device Sequence Number: 16384947
• Product Code: HQL
• UDI-Device Identifier: 05050474558182
• UDI-Public: (01)05050474558182(17)200321
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2017

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: 03/21/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1