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

Model Number	ZCT300
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, not provided.Implant and explant dates: if implanted or explanted, give date: not applicable as the lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that while loading an intraocular lens (iol) into the cartridge, a small blue particle was noticed on the lens, believed to be inside the optic.The surgeon inspected the lens and tried to scrape the particle off the lens and also thought that the particle was integrated into the optic.The iol was not implanted and there was no patient contact.Reportedly the amo sales representative collected the lens to be inspected by the manufacturing site, and the particle had fallen off the iol and remained on the inside of the packaging.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection using a 12x microscope magnification showed that the lens was contaminated, dust particles were present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Both sides of the lens contained non process related foreign matter.There was insufficient material to perform additional analysis.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 similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5992413
• Report Number: 9614546-2016-00489
• Device Sequence Number: 1896696
• Product Code: HQL
• UDI-Device Identifier: 05050474553026
• UDI-Public: (01)05050474553026(17)200419
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2016

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: 04/19/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 12/05/2016
• 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: CARTRIDGE 1MTEC30, LOT UNKNOWN