MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a z9002 14.0 diopter intraocular lens (iol) was explanted.The lens was replaced with the same model lens, a larger, 16.5 diopter lens.There was no incision enlargement no sutures and no patient injury.No further information was provided.
Additional Manufacturer Narrative
Upon further review, it was observed that the information in pma/510(k) of the initial report was incorrect.The pma/510(k) # in the initial report states p980040, but the correct pma/510(k) number for the device in this event is p880081.Pma/510(k) # p880081.Additional information confirming that the lens was removed for refractive purposes because patient outcome was not as expected.There was no complications and no product issues.Device available for evaluation ¿ yes, returned to manufacturer on 07/31/2017.Device returned to manufacturer ¿ yes.Device evaluation : the device was returned to the manufacturer.The lens was received cut in two pieces.What appear to be blood, viscoelastic residues and slightly scratches were observed.The haptics looks positioned.The condition of the lens is typically of a removed or an explanted lens.No major defects were observed in the lens.The complaint was not verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no other complaints have been received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6730162
• Report Number: 2648035-2017-01306
• Device Sequence Number: 10953114
• Product Code: HQL
• UDI-Device Identifier: 05050474530577
• UDI-Public: (01)05050474530577(17)210309
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 08/28/2017

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: 03/09/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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