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

Model Number	AR40E
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.Initial reporter phone: (b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The intraocular lens (iol) was folded, so the physician could not perform the procedure.During follow-up, it was found that the problem was detected during the procedure.The iol had contact with the patient's right eye.The iol was not implanted.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 03/01/2017.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 was observed with one lens haptic distorted/bent.Residues of what appears to be ophthalmic viscoelastic (ovd) was observed on the lens optic body.The customer's reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other complaints were received for this order number to date.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: 6274971
• Report Number: 2648035-2017-00162
• Device Sequence Number: 830996
• Product Code: HQL
• UDI-Device Identifier: 05050474502253
• UDI-Public: (01)05050474502253(17)190829
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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: 08/29/2019
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2017
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1