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

Model Number	ZLB00
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as the lens remains implanted.Lens explant planned.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zlb00 intraocular lens (iol) is planned to be explanted and replaced with a zmb00 iol to improve patient's near vision.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information was received confirming that the explant occurred on (b)(6) 2016.Additionally, it was learned that the explant was attributed to lens mechanical complications; however, no specific details were provided.No further information was available.If explanted, give date: (b)(6) 2016.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 02/6/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed and it can be seen that a haptic was missing.The damage is not product related.Visual inspection of the return sample shows the product is damaged and incomplete, most probably to make explant possible.The complaint cannot be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer 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: 6143426
• Report Number: 9614546-2016-00653
• Device Sequence Number: 11074818
• Product Code: MFK
• UDI-Device Identifier: 05050474560734
• UDI-Public: (01)05050474560734(17)200525
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/25/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/16/2017; 04/05/2017
• 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