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

Model Number	PCB00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a pcb00 26.5 intraocular lens (iol) was implanted on (b)(6) 2017 into the patient's right eye (od).It was later explanted on (b)(6) 2017 due to a diopter error.Reportedly sutures were required and another lens of the same model was used.No additional information was provided.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2018, indicated that patient is doing great post op and the doctor did not pick an incorrect lens power as initially reported.Device available for evaluation? yes.Returned to manufacturer on: 12/22/2017.Device returned to manufacturer? yes.Device evaluation: the sample was returned to the manufacturer.The lens were received in a plastic sample container and was cut in two pieces.Therefore, further analysis and a diopter measurement could not be performed on the returned lens.The customer's reported issue could not be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the mrr (manufacturing record review).A search of the complaints revealed that no additional complaint were received from this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer 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 92705
• MDR Report Key: 7103000
• Report Number: 2648035-2017-02245
• Device Sequence Number: 1933355
• Product Code: HQL
• UDI-Device Identifier: 05050474558397
• UDI-Public: (01)05050474558397(17)190807
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/07/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 12/10/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention