MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS INTRALASE; PATIENT INTERFACE

Model Number PI-RET

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Surgeon reported that patient was applanated and laser was fired completing the flap.When they pulled the suction ring/patient interface off the eye, the surgeon realized the flap was off-center.The surgeon aborted the excimer treatment.Account reported that there was no clinical issue to report and the patient is doing fine because the surgeon did not lift the flap.No issues or complications occurred with the patient.

Manufacturer Narrative

(b)(4).Account reported that surgeon is re-scheduling the patient 3 months out (probably mid-november) to let the eye and off-centered flap heal.All pertinent information available to abbott medical optics has been submitted.Placeholder.

Manufacturer Narrative

Manufacturing record review was completed and device was manufactured according to specifications.

Manufacturer Narrative

Device returned and evaluated by manufacturer.Product was evaluated.Visual and dimensional testing was conducted and no failures were detected.However, the functional test could not be performed since the sample received was incomplete.

• Brand Name: INTRALASE
• Type of Device: PATIENT INTERFACE
• 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: valerie sedzicki ; 1700 east st. andrew place; sa3m - c3051; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 4141361
• MDR Text Key: 17613853
• Report Number: 2648035-2014-00525
• Device Sequence Number: 1
• Product Code: HNO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/04/2016
• Device Model Number: PI-RET
• Device Catalogue Number: PI-RET
• Device Lot Number: CP00777
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2014
• 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
• Patient Outcome(s): Other