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

Model Number	ZA9003
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	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the haptic got caught in the pupil and had to be cut out and changed to an anterior lens.During follow-up, the complaint reporter stated that after the lens was inserted into the eye, it did not unfold properly.A haptic got caught in the pupil.Therefore, the doctor had to cut the lens to remove it.The lens was removed with no incision enlargement, vitrectomy or patient injury.A different lens was inserted in the anterior chamber with no other complications.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Visual inspection at 10x microscope magnification was performed.The lens was received cut in two parts.One lens haptic was observed detached.The detached haptic piece was not returned.The other lens haptic was observed distorted.The lens condition observed is consistent with a unit that has been cut due to ¿iol removal process or explant¿.Loose particles were observed on the sample which indicates handling of the lens out of the sterile environment.Residue of viscoelastic was detected on the sample.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.The directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.The reported issue was not verified.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
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5982409
• Report Number: 2648035-2016-01523
• Device Sequence Number: 80699
• Product Code: HQL
• UDI-Device Identifier: 05050474529144
• UDI-Public: (01)05050474529144(17)170514
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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): 10/27/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/14/2017
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 10/27/2016
• 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