MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1 MULTIFOCAL; MULTIFOCAL IOLS

Model Number	ZLB00
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was not implanted.If 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 the tip of inserter (cartridge) was bent and when the intraocular lens (iol) tried to advance, the lens and the lens haptic tore.No patient contact reported.No further information was provided.This mdr is for the lens.A separate mdr will be filed for the cartridge.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 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.The condition of the return sample do not suggest that there was a product deficiency introduced during manufacturing.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 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 and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6119645
• Report Number: 9614546-2016-00625
• Device Sequence Number: 16455809
• Product Code: MFK
• UDI-Device Identifier: 05050474560765
• UDI-Public: (01)05050474560765(17)190609
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2016

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: 06/09/2019
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 12/20/2016
• 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: 1MTEC30 CARTRIDGE, LOT UNKNOWN