MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS S4; EXCIMER LASER

Model Number 0030-4638

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Code Available (3191)

Event Date 01/15/2014

Event Type  Injury  

Event Description

The clinic reported that patient presented with undercorrection post treatment of -1.25.Surgeon said that laser was not powerful enough.

Manufacturer Narrative

(b)(4): (undercorrection).Field service specialist visited the account and checked the system and there was no technical trouble found.Minor adjustment was done as it was found slightly positive but within range.Surgeon was in doubt during this session because he said he was not able to see the beam shots on screen as he is used to watch, giving him the impression the beam was not powerful enough.Field service specialist explained that if a power loss occurs the system would stop and report an error condition, which was not the case.All pertinent information available to abbott medical optics has been submitted.Placeholder.

• Brand Name: S4
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: valerie sedzicki ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478567
• MDR Report Key: 3782323
• MDR Text Key: 4432316
• Report Number: 3006695864-2014-00256
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P930016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 0030-4638
• Device Catalogue Number: 0030-4638
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention