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

Model Number	AAB00
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: unknown, not provided.If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.(b)(6).(b)(4).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported opacification of an intraocular lens (iol).Additional information was received and it was learnt that the lens was successfully implanted into the eye of (b)(6) male patient.At the two weeks post-op visit there was fibrin reaction, and at follow-up visit on (b)(6) opacification of the iol was seen.Reportedly, two weeks later the surgeon was unable to reach for the patient and he thinks that probably the issue has been resolved.No further information was provided.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5998976
• Report Number: 2648035-2016-01548
• Device Sequence Number: 10979755
• Product Code: HQL
• UDI-Device Identifier: 05050474548664
• UDI-Public: (01)05050474548664(17)200405
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/05/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 10/05/2016
• 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: Other
• Patient Age: 68 YR