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 Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) had some sort of film on it that looked like a sheen.The surgeon noticed it as soon as the iol was injected into the eye.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Additional information: during follow up, it was found that the lens remains implanted.Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and 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) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.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.
Additional Manufacturer Narrative
Through follow up it was learned that the cartridge was discarded and the iol remains implanted.Furthermore, it was learned that the patient is doing fine.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6645742
• Report Number: 2648035-2017-01075
• Device Sequence Number: 19009510
• Product Code: HQL
• UDI-Device Identifier: 05050474529113
• UDI-Public: (01)05050474529113(17)220427
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2017

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: 04/27/2022
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 06/29/2017; 08/23/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/24/2017; 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1