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

Model Number	ZKB00
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zkb00 25.5 diopter intraocular lens (iol) became stuck in an unknown cartridge model upon insertion into the patient's operative eye, which caused a haptic to break.Reportedly, there was no patient contact; however, this was not confirmed.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 01/18/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection shows the lens was received in lens case.The product was inspected using a 12x magnification and showed some traces of opthalmic viscosurgical devices (ovd) on both sides of the lens surface.The lens was cleaned with 2% liquinox and a swab to ease the inspection.The traces of ovd can be removed.Visual inspection of the cleaned lens shows no abnormality or crack found on the haptic area.Observed deep scratches at the optic area but this type of scratches will be rejected during manufacturing as per hb0017.Lens was further measured and all measurements were within specification.The complaint event cannot be confirmed.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 other complaints were 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 92705
• MDR Report Key: 7183285
• Report Number: 3011852734-2018-00005
• Device Sequence Number: 18873106
• Product Code: MFK
• UDI-Device Identifier: 05050474560192
• UDI-Public: (01)05050474560192(17)210710
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/01/2018

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: 07/10/2021
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1