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

Model Number	PCB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The device was not used.The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The device was not used.The intraocular lens was not implanted; therefore, not explanted.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the cartridge tip was deformed and could not be used.There was no patient involvement/injury.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 11/08/2017.Device returned to manufacturer?: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual evaluation using microscope magnification showed the plunger component was received not locked.The cartridge was observed correctly engaged into lower body of the pcb00 device.The lens of the preload system was observed stuck and torn at the cartridge tip.The cartridge tip is observed deformed, the reported issue 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 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 was 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: 6867574
• Report Number: 2648035-2017-01660
• Device Sequence Number: 99501
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)191112
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2017

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: 11/12/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1