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

Model Number	Z9002
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was first reported that the intraocular lens (iol) did not insert into the patient's eye and had a malfunction.The doctor was able to remove the iol and use a new one of the same model and diopter.The patient is fine.During follow-up, it was found that after the lens was inserted in the eye, the doctor did not like how the lens unfolded in the eye.The lens was cut in pieces and removed from the patient with no incision enlargement, vitrectomy or patient injury.Another lens of the same model and diopter was inserted with no complications.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 09/30/2016.Device returned to manufacturer: yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed loose particles/fibers in the optic body compatibles with handling the lens out of the sterile environment.The lens was observed unfolded.No damages in the lens haptics were observed.The customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6042657
• Report Number: 2648035-2016-01630
• Device Sequence Number: 16157025
• Product Code: HQL
• UDI-Device Identifier: 05050474530621
• UDI-Public: (01)05050474530621(17)180810
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 11/28/2016

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: 08/10/2018
• Device Model Number: Z9002
• Device Catalogue Number: Z900200165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2016
• Supplement Report FDA Received Date: 11/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1