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

Model Number	PCB00
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted, give date: not applicable, there is no indication the lens was implanted.If explanted, give date: not applicable, there is no indication the lens was implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the lens box of a pcb00 12.5 diopter intraocular lens (iol) had a note on it stating the tip was bent.Reportedly, this was during handling, but prior to insertion.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 10/10/2017.Device returned to manufacturer? yes.The sample was evaluated.The plunger was not advanced nor locked as required.Inspection at 10x under microscope magnification was performed.The device was observed handled, and the cartridge tip was observed deformed.The lens was not received out of the device or inside the cartridge.There were no viscoelastic residues observed inside the cartridge.The reported complaint was confirmed.One probable cause could be that the lack of viscoelastic causing friction/resistance, which may lead to deformation of the cartridge.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.The directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.As a result of the investigation, there is no indication of a product quality deficiency.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6880838
• Report Number: 2648035-2017-01681
• Device Sequence Number: 13484137
• Product Code: HQL
• UDI-Device Identifier: 05050474558113
• UDI-Public: (01)05050474558113(17)191117
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/20/2017

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: 11/17/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1