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

Model Number	Z9002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was not implanted and therefore not explanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that speck was noticed on an intraocular lens (iol) during handling, but prior to insertion.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 11/15/2017 device returned to manufacturer? yes.Device evaluation: the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.A black particle was observed on the lens surface.No damaged was observed to the lens and lens haptic.The lens was analysed using the fourier transform infrared (ftir) spectroscopy.The results revealed that the dark particle is consistent with a mixture of kaolin (china clay or aluminum silicate) and an acrylic species, or may be a kaolin filled acrylic based adhesive.Through the manufacturing process there are various cleaning operations and 100% visual inspection utilizing a 10x microscope magnification.Any defects on the lenses or lens loops that do not meet the criteria specifications are rejected in the manufacturing area.The complaint issue reported was verified.However, with the information provided, the dark particle observed in the iol could not be associated to the manufacturing process.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.During the record review for production order, no deviation was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search of the complaint database was performed and revealed no additional investigation request for this production order number.In addition sterilization records were reviewed: sterilization was processed and no deviations were found that affects the sterility of the device.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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: 6989546
• Report Number: 2648035-2017-01991
• Device Sequence Number: 19003824
• Product Code: HQL
• UDI-Device Identifier: 05050474530812
• UDI-Public: (01)05050474530812(17)211027
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 01/11/2018

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: 10/27/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1