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

Model Number AR40E

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: the product was not returned for evaluation as it was discarded at the surgery site.Therefore, an investigation could not be performed and the reported event could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specifications.There are no discrepancies found during the review.The documentation shows that the production order was manufactured according to specifications.There is no associated deviation or non-conformity report found in the review that was related to the customer's event.Lenses were released according to specification and in compliance with the product intended use as required.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: the reported issue was not verified.As a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

Event Description

The intraocular lens (iol) was removed and replaced within the same procedure as a bent haptic was reported.The lens was fully inserted with one haptic hanging out.There was no patient injury.The incision was enlarged.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Additional information was received: the lens was removed and replaced on (b)(6) 2016.Date of event: (b)(6) 2016.If implanted; give date: na (not applicable) lens removed/replaced during same surgery.If explanted; give date: na (not applicable) lens removed/replaced during same surgery.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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 5992298
• MDR Text Key: 56095045
• Report Number: 2648035-2016-01536
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474501867
• UDI-Public: (01)05050474501867(17)210604
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/04/2021
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2016
• 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
• Patient Outcome(s): Required Intervention