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

Model Number	AR40E
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Undefined medical or surgical intervention.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during/after insertion of an intraocular lens (iol) into the patient's eye, the haptic was noticed to be bent and the lens had to be cut out.Reportedly, an undefined medical or surgical intervention was required to avoid injury or impairment.The intervention was not identified.No further information was provided.
Additional Manufacturer Narrative
Additional information/corrected data: additional information was received and it was reported that there was no patient injury.The intraocular lens (iol) was removed and replaced during the same surgical procedure.This event has now been determined not to be a reportable event.(b)(4).No further reports will be sent for this file.Device available for evaluation ¿ yes, returned to manufacturer on 04/13/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and the lens returned was observed cut in two pieces.Fibers/particles were observed on lens pieces related to the handling of the unit out of non-sterile environment.Residues of viscoelastic were also observed on sample which indicated that the unit was handled and prepare for surgical used.One of the haptic was observed bent.The complaint issue reported was verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigations requested for this po number.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 abbott medical optics has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6443951
• Report Number: 2648035-2017-00587
• Device Sequence Number: 1200231
• Product Code: HQL
• UDI-Device Identifier: 05050474501881
• UDI-Public: (01)05050474501881(17)190606
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

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: 06/06/2019
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE EMERALDC30, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention