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

Model Number	ZKB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Implant date: if implanted; give date: n/a the blemish was noticed prior to insertion of the intraocular lens and therefore the lens was not implanted.Explant date: if explanted; give date: n/a as the lens was not implanted it was therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The customer reported a blemish (particle or smudge) on the center of the intraocular lens (iol).The blemish was noticed during handling of the iol but prior to insertion.The physician was not comfortable using the lens.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 09/29/2016.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed the 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.On the optic of the lens some non-process related blemish and smudge could be seen.The condition of the return sample do not suggest that the blemish and smudge were introduced during manufacturing; the product was used or prepared for use.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The complaint related test is the cosmetic inspection performed at final inspection.Only units that meet cosmetic inspection criteria are then subject to optical inspection.The in-line optical inspection data shows the lens is within power specification; hence the lens meets the specified cosmetic requirements.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 was 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: 5955066
• Report Number: 9614546-2016-00465
• Device Sequence Number: 79777
• Product Code: MFK
• UDI-Device Identifier: 05050474560130
• UDI-Public: (01)05050474560130(17)190330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/28/2016

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: 03/30/2019
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0225
• 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: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 11/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1