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

Model Number	AR40E
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was inserted and removed from the eye of a (b)(6) female patient, because there was a fissure in the middle of the optic zone.It was also reported that lens was too rigid.Reportedly, there was a delay of 40 minutes in the procedure.No secondary medical intervention was required.At a later date, further information was provided.It was reported that the lens was broken (no detail provided), the lens was not implanted and new lens, same model and diopter was implanted.There was no patient injury and the patient outcome is stable.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 investigation requests 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 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: 6985481
• Report Number: 2648035-2017-01971
• Device Sequence Number: 1117873
• Product Code: HQL
• UDI-Device Identifier: 05050474502185
• UDI-Public: (01)05050474502185(17)220125
• 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): 06/04/2018

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: 01/25/2022
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR