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

Model Number	AR40M
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant dates: if implanted or explanted, give date: unknown, information not provided.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 the intraocular lens was observed torn.Reportedly, the lens was torn during handling; prior to insertion, however, this was not confirmed.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 1/18/2018.Device returned to manufacturer: yes.Device evaluation: the ar40m lens was received in the original packaged.The lens was returned cut in two pieces.Visual inspection using microscope magnification was performed.One lens haptic was observed detached.The detached haptic piece was not returned.Evidence of viscoelastic residue was detected on the lens optic body.The condition observed in the lens is consistent with a lens that has been handled and prepared for surgical use.The reported issue was verified.However, due the condition of the sample received (cut in half), there was no evidence to suggest that the returned lens has been affected by the manufacturing process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 & 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: 7161393
• Report Number: 2648035-2018-00009
• Device Sequence Number: 13919260
• Product Code: HQL
• UDI-Device Identifier: 05050474514201
• UDI-Public: (01)05050474514201(17)210721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/28/2018

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: 07/21/2021
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1