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

Model Number	ZA9003
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If explanted; give date: not applicable as there is no indication lens was explanted.Device evaluation: the device was not available for evaluation as it remains implanted.The reported issue could not be verified.Manufacturing records review: the manufacturing records for the product 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.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
It was reported that the doctor placed the intraocular lens (iol) in the sulcus due to an anterior rant (no vitreous loss).After the iol was injected, the doctor noticed a scratch on the lens.The scratch was off center.An experienced technician loaded the lens and the doctor doesn¿t believe the technician damaged the lens.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: 6357001
• Report Number: 2648035-2017-00365
• Device Sequence Number: 11023515
• Product Code: HQL
• UDI-Device Identifier: 05050474528819
• UDI-Public: (01)05050474528819(17)210225
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: 02/25/2021
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1