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	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted, give date: not applicable no patient contact reported.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was noticed torn when opening the lens case.No patient contact was reported.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 8/17/2017.Device returned to manufacturer? yes.Device evaluation: the complaint unit was received in the original folding carton.Visual inspection using microscope magnification was performed.The lens was observed with one haptic detached (cut more than half of the loop).The detached haptic piece was not returned.The other haptic was observed in good shape and form.No defects on the lens optic such as tears/cuts were observed on the returned unit.Loose particles were observed on the lens consistent with handling of the iol out of a sterile environment.The reported issue was not confirmed.However, haptic detached was observed on the return.There is no evidence to suggest that the lens has been affected by the manufacturing process.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6620613
• Report Number: 2648035-2017-01014
• Device Sequence Number: 19034862
• Product Code: HQL
• UDI-Device Identifier: 05050474530577
• UDI-Public: (01)05050474530577(17)190228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/11/2017

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: 02/28/2019
• Device Model Number: Z9002
• Device Catalogue Number: Z900200140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1