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

Model Number AR40E

Device Problems Bent (1059); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was initially reported that upon opening the lens case of an intraocular lens (iol), one haptic was noticed detached and deformed.The lens was not used and the surgeon implanted another iol, of a near diopter, as there was no back-up lens with the same diopter available.The operation was delayed of around 5 minutes.No patient injury reported.A photo of the lens was provided and it was observed that the lens was actually torn; a piece of the optic material including one complete haptic (still intact inside the radial hole of the lens) was completely torn away from the rest of the iol optic.No further information was provided.

Manufacturer Narrative

The intraocular lens (iol) was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the lens had part of the optic section broken (near the edge).One lens haptic was observed distorted.The other haptic was observed detached.The detached haptic had a piece of the optic material attached to it.A depression mark (shaped arc) was observed across the lens optic surface.The condition observed was consistent with a iol that wasn¿t mounted properly into the lens case, and when it was closed the lens was damaged.The customer's reported complaint was verified.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.During manufacturing the lens must be positioned straight in the insert/lens case assembly so that the lens sits between the insert pegs.Operators must verify that the lens is mounted properly in its case.A search revealed that no additional complaints for this order number have been received.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 an indication of a product quality deficiency.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: 5828271
• MDR Text Key: 50616420
• Report Number: 2648035-2016-01179
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

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
• Device Operator: Physician
• Device Expiration Date: 08/21/2020
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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