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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was inserted and removed.If explanted, give date: not applicable as the lens was inserted and removed.(b)(4).Device evaluation the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue 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 device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported a ar40e 25.0 diopter intraocular lens (iol) was inserted and removed from a female patient's right eye.According to the physician the lens was folded and checked by technician and representative.Upon attempt to implant the physician noticed the eye filled with blood, iol was removed and could not be used due to the patient's eye.Through follow-up it was learned that the doctor possibly nicked the iris or other parts of the eye while dissecting back conjunctiva and making a hole in the sclera.The lens had nothing to do with this part of the procedure.Iol was removed as a whole.No issue with iol, patient anatomy and complication with procedure led to removal of the perfectly implanted lens.At removal the incision was enlarged and sutured.There was no vitrectomy.The reason the patient was there was because they had already had a vitrectomy from a previous surgical complication.Patient had no ¿bag¿ for normal lens placement and so the physician was trying to sew in a lens for the patient.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6724072
• Report Number: 2648035-2017-01289
• Device Sequence Number: 983421
• Product Code: HQL
• UDI-Device Identifier: 05050474502208
• UDI-Public: (01)05050474502208(17)220209
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 02/09/2022
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/19/2017
• 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