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

Model Number	ZA9003
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.If implanted, give date: not applicable as the lens was inserted and removed.If explanted, give date: not applicable as the lens was inserted and removed.(b)(6).Device evaluation the device was returned to the manufacturer.The lens was observed cut in four parts.Optic appears cut and ripped/torn.Visual inspection at 10x microscope magnification was performed and small particles that could be related to handling the unit out of a controlled environment are observed on the surface of the iol parts.Residues of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) were detected on the iol , indicating the device was handled and prepared for surgical use.Due to the condition of the returned lens, the reported device problem could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.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 intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after the insertion of za9003 into a patient's eye, the physician noticed dots/marks on the lens.The lens was removed and replaced with a new lens.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: 6370211
• Report Number: 2648035-2017-00389
• Device Sequence Number: 442889
• Product Code: HQL
• UDI-Device Identifier: 05050474529106
• UDI-Public: (01)05050474529106(17)210715
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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: 07/15/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1