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

Model Number AR40E

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Undefined medical or surgical intervention.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that during/after insertion of an intraocular lens (iol) into the patient's eye, the haptic was noticed to be bent and the lens had to be cut out.Reportedly, an undefined medical or surgical intervention was required to avoid injury or impairment.The intervention was not identified.No further information was provided.

Manufacturer Narrative

Additional information/corrected data: additional information was received and it was reported that there was no patient injury.The intraocular lens (iol) was removed and replaced during the same surgical procedure.This event has now been determined not to be a reportable event.(b)(4).No further reports will be sent for this file.Device available for evaluation ¿ yes, returned to manufacturer on 04/13/2017.Device returned to manufacturer ¿ yes.Device evaluation the device was returned to the manufacturer.Visual inspection at 10x microscope magnification was performed and the lens returned was observed cut in two pieces.Fibers/particles were observed on lens pieces related to the handling of the unit out of non-sterile environment.Residues of viscoelastic were also observed on sample which indicated that the unit was handled and prepare for surgical used.One of the haptic was observed bent.The complaint issue reported was verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no additional investigations requested for this po number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no 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: 6443951
• MDR Text Key: 71200575
• Report Number: 2648035-2017-00587
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474501881
• UDI-Public: (01)05050474501881(17)190606
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

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
• Device Operator: Physician
• Device Expiration Date: 06/06/2019
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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
• Treatment: CARTRIDGE EMERALDC30, LOT UNKNOWN
• Patient Outcome(s): Required Intervention