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

Model Number	ZLB00
Medical Device Problem Codes	Torn Material (3024); Device Handling Problem (3265)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A report was received that a tecnis 1 multifocal (tmf) model zlb00 intraocular lens (iol) was removed and replaced from the patient¿s operative eye during the same procedure due to iol was cracked/torn.The surgery center indicated the cracked/torn iol was a result of use/handling error and no complaint on the iol device.An incision enlargement was required to remove the original iol.The removed iol was destroyed and discarded by the surgery center.The replacement lens was another zlb00 iol.It is noted that a non-validated, non-amo cartridge was used in the procedure which may have contributed to the reported issue.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site.Therefore, product testing could not be performed and 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 on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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: 6444919
• Report Number: 9614546-2017-00253
• Device Sequence Number: 830101
• Product Code: MFK
• UDI-Device Identifier: 05050474560550
• UDI-Public: (01)05050474560550(17)200215
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2017

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: 02/15/2020
• Device Model Number: ZLB00
• Device Catalogue Number: ZLB00U0140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 08/31/2017
• 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: MONARCH INSERTER/CARTRIDGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR