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

Model Number	AR40E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates: if explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was initially reported that the doctor noticed a film on the intraocular lens (iol) prior to insertion.As a result of follow up it was learned that the iol was fully inserted and was removed.There was no vitrectomy, no incision enlargement, no serious patient injury however one suture was required.The procedure was completed successfully using backup lens with same model and diopter size no additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation? yes, returned to manufacturer on 7/14/2017.Device returned to manufacturer? yes.Device evaluation: the product was returned for evaluation.The lens returned was cut in half.Loose fibers/particles were observed on the lens piece which is related to the handling of the unit out of a sterile environment.The return indicates that the lens was in the patient¿s eye; it was returned with potentially blood and dried viscoelastic solution.One of the haptics was returned detached and distorted.The reported film and/or debris could not be identified.Due to the conditions of the lens, it could not be sent for further analysis.The complaint issue could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional investigation requests have been received for this order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Conclusion: as a result of the investigation, 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: 6666077
• Report Number: 2648035-2017-01139
• Device Sequence Number: 16637336
• Product Code: HQL
• UDI-Device Identifier: 05050474514102
• UDI-Public: (01)05050474514102(17)210805
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/15/2017

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: 08/05/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 06/25/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1