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

Model Number	AR40M
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	10/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown if the lens was fully implanted.If explanted, give date: unknown if the lens was fully implanted and therefore unknown if explanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during implantation, an intraocular lens (iol) would not unfold correctly because the insertion was too small.Further information was provided and reports the lens was inserted into the eye.An incision enlargement, suture, and vitrectomy were required.The procedure was completed successfully with another lens.The patient outcome was reported as good.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 12/14/2016.Device returned to manufacturer ¿ yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturer.Visual inspection was performed at 10x microscope and no product damaged was observed to the lens.Fibers/particles were observed on lens related to the handling the lens.Residue of viscoelastic solution were also observed which indicated that the unit was handled and prepare for surgical use.The complaint issue reported could not be verified.The lens issue could not be confirmed in the returned sample.Manufacturing records were reviewed and the lens was manufactured according to specification.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 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: 6105098
• Report Number: 2648035-2016-01804
• Device Sequence Number: 680342
• Product Code: HQL
• UDI-Device Identifier: 05050474501829
• UDI-Public: (01)05050474501829(17)210715
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/15/2021
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention