MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SENSAR; MONOFOCAL IOLS

Model Number	AAB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that when removing from the package, a hair was found on the intraocular lens (iol).No patient contact reported.No further information was provided.
Additional Manufacturer Narrative
Device evaluation the device was returned to the manufacturer.Visual inspection was performed and one fiber or hair like was observed on top of the lens/insert.No debris/particles were observed inside the lens/insert or on the lens optic surface.Also, no debris/particles were observed on the lens haptics.The foreign material looks like purple in color.The reported ¿debris / particles¿ was confirmed on the returned sample.The particle was analyzed by ftir (fourier transform infrared), spectroscopy results revealed the foreign material is consistent with a mixture of cellulose (i.E.Cotton, rayon, lint) and an inorganic carbonate, likely calcium carbonate.According amo subject matter expert (sme) assessment stated with the information provided concluded, these debris are not associated to the manufacturing process.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.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: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5912736
• Report Number: 2648035-2016-01350
• Device Sequence Number: 18946524
• Product Code: HQL
• UDI-Device Identifier: 05050474548671
• UDI-Public: (01)05050474548671(17)190722
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/09/2016

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: 07/22/2019
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1