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

Model Number	AR40E
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	10/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: implanted sometime in (b)(6) (year not provided).If explanted, give date: not applicable.Customer indicated that lens was too rigid and scissors were too large to get the lens out.Therefore based on this information it is unclear if it was explanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a patient had an iris prolapse.The lens was originally implanted in (b)(6) (year not provided).The lens was upside down and piggy backed to another lens.Lens was too rigid and scissors were too large to get the lens out.Sutures were required.No other information was provided.
Additional Manufacturer Narrative
Additional information: through follow up it was learned that the lens was explanted from a female patient's right eye.It was clarified that during insertion the lens rotated upside down and piggy backed to another lens.Patient had anisometropia.Visual acuity issue was noted.There was no vitrectomy or patient injury post-op.However, incision enlargement was required.Lens was replaced with an ar40 lens.Age/date of birth: (b)(6).Gender/sex: female.If implanted, give date: (b)(6) 2016.If explanted, give date: (b)(6) 2016.Additional reporter - (b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 12/20/2016.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Device inspection was performed and visual inspection was performed at 10x microscope magnification.Fiber/particles were observed on lens related to the handling of the unit in a non-sterile environment.Residues of viscoelastic solution were observed on lens which indicates that the unit was handled and prepared for surgical use.Lens was observed with two cuts most probably to make the explant process possible.One of the haptics was observed slightly distorted.The complaint issue reported could not be verified.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 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: 6108384
• Report Number: 2648035-2016-01820
• Device Sequence Number: 1169221
• Product Code: HQL
• UDI-Device Identifier: 05050474501850
• UDI-Public: (01)05050474501850(17)210511
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 05/11/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 12/15/2016; 12/28/2016
• 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
• Patient Age: 72 YR