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	08/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown, not provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was implanted and then doctor noticed there was not enough capsule for the lens.The lens was removed and an anterior chamber lens implanted.An incision enlargement was required to remove the lens.No further information was provided.
Additional Manufacturer Narrative
Through follow up, the customer confirmed that the issue was definitely a patient issue and not due to the lens.There was no vitrectomy performed and no sutures were used.There was no post-op issues reported.Device evaluation: the intraocular lens (iol) was returned to the manufacturer for evaluation.Visual inspection at 10x microscope magnification was performed and the lens has residues of viscoelastics.The lens haptics are distorted.This could be related to the removal process.There is no specific complaint against the lens.There is no indication that the issue reported is related to the quality of the lens.Manufacturing records were reviewed and the lens was manufactured according to specification.There were no non conformances with respect to the manufacturing process.There were no associated nonconformity reports or deviations.A search on complaints revealed no other complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.As a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5958979
• Report Number: 2648035-2016-01470
• Device Sequence Number: 19042520
• Product Code: HQL
• UDI-Device Identifier: 05050474530775
• UDI-Public: (01)05050474530775(17)210303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2016

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: 03/03/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2016
• Supplement Report FDA Received Date: 11/04/2016
• 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
• Patient Age: 70 YR