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

Model Number	PCB00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lens was removed in the initial surgery.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens was observed torn while inserting into the eye which was removed in the same surgery.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation, returned to manufacturer on: 1/16/2018.Device evaluation: the sample was evaluated.The plunger was fully advanced and locked as required for product preparation.There was no assembly issues identified.No damage on the cartridge was observed.There was no viscoelastic residue observed inside the cartridge.The lens was received out of the device and it was observed cut in two.Based on the inspection the complaint was verified.However, it cannot be confirmed if the lens was torn or it was cut due to the removal process performed.Therefore, it is not possible to confirm if the defect observed is related to manufacturing, as the reported lens was handled and implanted.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 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: 7174033
• Report Number: 2648035-2018-00054
• Device Sequence Number: 16367812
• Product Code: HQL
• UDI-Device Identifier: 05050474558090
• UDI-Public: (01)05050474558090(17)200114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/27/2018

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: 01/14/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1