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

Model Number AR40M

Device Problem Bent (1059)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: unknown if the lens was implanted.If explanted, give date: unknown if the lens was implanted and unknown if explanted.Device evaluation: the intraocular lens (iol) was returned at the manufacturing site inside the lens case but it was not correctly positioned.Visual inspection at 10x microscope magnification showed loose particles and viscoelastic residue on the lens surface.The haptics were observed distorted.The customer's reported complaint was verified.However, it was not possible to determine if the distortion of the haptics was related to how the lens was positioned within the case.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.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 was verified.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) had an haptic bent.No further information was provided.

Manufacturer Narrative

The customer confirmed the following requested information: here was no patient contact with the intraocular lens (iol).The doctor used a backup iol.There was no incision enlargement, sutures, or vitrectomy.The patient was fine after the surgery.No issues were observed.Note: based on the additional information reported above, this event is no longer considered reportable.(b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: SENSAR
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6632637
• MDR Text Key: 77318121
• Report Number: 2648035-2017-01039
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474514249
• UDI-Public: (01)05050474514249(17)220331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1