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

Model Number	ZA9003
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection at 10x microscope magnification was performed.The haptics were observed to be distorted.Residues of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) was detected on the lens surface.Small particles that could be related to handling the unit out of a controlled environment were observed on the lens surface.The reported black particles could not be identified although debris / particles are observed / verified on the retuned lens.Manufacturing records review: 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.Labeling review: 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.Conclusion: the reported issue (black particles) 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.
Event or Problem Description
The dr.Reported that the intraocular lens (iol) was defective.The defect was noticed prior to loading the iol into the cartridge.The dr.Was able to use another iol of the same model and diopter.The patient's outcome is satisfactory.Amo received information from the customer clarifying that he believes there was black debris on the iol.The lens or cartridge did not touch the eye.No injury to the patient.No additional information was provided to abbott medical optics.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6082057
• Report Number: 2648035-2016-01754
• Device Sequence Number: 1626106
• Product Code: HQL
• UDI-Device Identifier: 05050474529120
• UDI-Public: (01)05050474529120(17)170409
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 11/05/2016

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: 04/09/2017
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1