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

Model Number	ZLB00
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.The doctor's full name was not provided.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was observed to be kinked/crimped during handling but prior to insertion.No patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 04/13/2017.Device returned to manufacturer? yes.Device evaluation: the product was received in a lens holder.The product was inspected by a qualified final inspection operator using 12x magnification.Investigation of the lens shows there is no product related damage.The complaint cannot be confirmed manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: 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 1 MULTIFOCAL
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6450605
• Report Number: 9614546-2017-00261
• Device Sequence Number: 13595090
• Product Code: MFK
• UDI-Device Identifier: 05050474560710
• UDI-Public: (01)05050474560710(17)200404
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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
• Report Date (Section B): 06/20/2017

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: 04/04/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1