MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant date: if implanted or explanted; give date: n/a (not applicable).The intraocular lens was not implanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
Initially it was reported that the intraocular lens (iol) tore on the inserter during handling but prior to insertion.The event was not related to user error.There was no patient contact.Through follow up it was clarified that the lens tore in the inserter, it was not inserted and it was confirmed there was no patient contact.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 02/16/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and small particles that could be related to handling the unit out of a controlled environment are observed on the surface of the iol.Residue of what appears to be viscoelastic ovd (ophthalmic viscosurgical device) was detected in the lens indicating the lens was handled and prepared for surgical use.The lens was observed torn in the center of optic zone.Both haptics were in good shape.Based on the evidence observed, the condition of the lens is consistent with a unit handled during a surgical process.The customer's reported issue was verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigation request 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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6324582
• Report Number: 2648035-2017-00266
• Device Sequence Number: 577696
• Product Code: HQL
• UDI-Device Identifier: 05050474530867
• UDI-Public: (01)05050474530867(17)200302
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 03/20/2017

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: 03/02/2020
• Device Model Number: Z9002
• Device Catalogue Number: Z900200285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1