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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown/not provided.Date of event: unknown.If implanted, give date: unknown/ not provided.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a zkb00 18.5 diopter intraocular lens (iol) was explanted.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 08/15/2017.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed the product was damaged on the anterior side and had some minor damage in the middle on the posterior side, most probably to make explant possible.The lens is contaminated and dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Investigation of the return sample and the condition of the return sample do not suggest the damage was introduced during manufacturing.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.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: 6790376
• Report Number: 9614546-2017-00735
• Device Sequence Number: 16171558
• Product Code: MFK
• UDI-Device Identifier: 05050474560055
• UDI-Public: (01)05050474560055(17)200315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 03/15/2020
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention