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

Model Number	AAB00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Date of event: unknown.It was reported that happened the week of (b)(6) 2017.If implanted, give date: unknown, not provided.If explanted, give date: not applicable as there is no indication that the lens was explanted.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that during the implantation of an intraocular lens (iol) the surgeon saw a small 0.2-0.4 millimetre bump/elevation on the anterior surface of the optic.Reportedly, the bump barely missed the center visual axis, so the surgeon decided to leave the lens in the eye.One day post-op the patient vision was 20/25 and the opacity could be seen just at the peripheral undilated pupil margin.Additional information was received and it was learnt that at around two weeks post-op the patient was examined and the spot was still noticed on the lens.The surgeon commented that it looked like a translucent flat material on the anterior surface of iol.The surgeon described the spot as like some clear nail polish.It seemed like the edges may be coming off a bit.The spot did not appear to be affecting the patient's vision.The doctor will continue to monitor the patient.No further information was provided.
Additional Manufacturer Narrative
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) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.The dfu states to examine the lens thoroughly to ensure particles have not become attached to it, and examine the lens optical surfaces for other defects.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 johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7077564
• Report Number: 3011852734-2017-00044
• Device Sequence Number: 1109503
• Product Code: HQL
• UDI-Device Identifier: 05050474548749
• UDI-Public: (01)05050474548749(17)201018
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 10/18/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/01/2017
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1