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

Model Number	AR40E
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens remains implanted.However, an explant / exchange is planned.(b)(6).(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported an ar40e 5.0 diopter intraocular lens (iol) was implanted on (b)(6) 2017.The patient complained of halos right after surgery, and during a post-operative examination, several scratches were observed on the lens in the patient''s eye.An iol replacement will be arranged.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported that the lens was explanted on 09/06/2017.No additional information was provided.With the information that has now been provided indicating that the lens has been explanted, report has been updated from other, serious to required intervention to prevent permanent impairment/damage.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 11/08/2017.Device returned to manufacturer?: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed the lens cut in three parts making it visually impossible to observe scratches (if any) on the three returned pieces of lens.Both lens haptics were observed broken/detached.Evidence of viscoelastic residues was observed on the lens pieces.The condition observed in the lens and the way in which the cut is formed is consistent with a lens that has been cut due to ¿iol removal or explant¿ process.The reported issues 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 on complaints revealed no additional complaints 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 abbott medical optics has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA 92705
• MDR Report Key: 6836727
• Report Number: 2648035-2017-01579
• Device Sequence Number: 19010757
• Product Code: HQL
• UDI-Device Identifier: 05050474501874
• UDI-Public: (01)05050474501874(17)200715
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2017

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: 07/15/2020
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 09/09/2017; 11/20/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/03/2017; 12/18/2017
• 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; Required Intervention