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

Model Number	ZA9003
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the lens was returned to the manufacturer for evaluation.Visual inspection at 10x microscope magnification showed residue of viscoelastic on the lens.Loose particles were also observed compatible with handling the lens out of the sterile environment.Only one half of lens with the haptic was received.The condition of the lens was consistent with a unit that has been cut due to iol removal process.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 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.
Event or Problem Description
It was reported that during implantation, the intraocular lens (iol) did not unfold properly in the patient's eye.The haptic got caught in the pupil and the surgeon had to cut the lens out of the eye.There was no incision enlargement, vitrectomy or patient injury reported.A different lens was inserted in the anterior chamber with no other complications.No further information was provided.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6006314
• Report Number: 2648035-2016-01563
• Device Sequence Number: 13532046
• Product Code: HQL
• UDI-Device Identifier: 05050474529144
• UDI-Public: (01)05050474529144(17)190929
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2016

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: 09/29/2019
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC30 CARTRIDGE, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention