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

Model Number AAB00

Device Problems Difficult To Position (1467); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

We received a report that during the implantation of a model aab00 intraocular lens (iol) the haptics stuck to the edge of the optic or at the back of the iol.The procedure was completed successfully and there was no patient injury reported.

Manufacturer Narrative

Pt age/date of birth: unknown.Pt gender/sex: unknown.Date of event: unknown.Implant date: unknown.Explant date: if explanted, give date: na (not applicable).The lens remains implanted initial reporter: telephone number: (b)(6).All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

A review of the manufacturing records was performed.All process operations presented in the manufacturing record from generation to boxing were in compliance with manufacturing instructions specifications.No deviation or non-conformance (ncr) related to the customer claim was generated when this production order was manufactured.A review of the raw material/manufacturing procedures in change control system was done during the period when this production order was manufactured and did not show any change in manufacturing method, inspections, or specifications that were related to the complaint reported.No other investigations requests have been received for this production order.The documentation showed that the production order was manufactured according to specifications.The lens met specifications prior to release.All pertinent information available to abbott medical optics has been submitted.Placeholder.

• 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: stephanie solomon ; 1700 east st. andrew place; santa ana, CA 92705 ; 7145663731
• MDR Report Key: 4708509
• MDR Text Key: 5647068
• Report Number: 2648035-2015-00243
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/10/2018
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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