MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER ILLUMINATED FLEX CURVED LASER PROBE, 25GA; LASER, OPHTHALMIC

Model Number 8065751593

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

A customer reported that when the surgeon attempted to remove the fiber optic during a vitrectomy procedure, the trocar cannula got stuck on the probe and came out of the eye with the fiber optic.During the same case, the same issue occurred with the curved laser probe.Between the two probes, the issue happened about three times.Each time, the surgeon reinserted the trocar and continued with surgery.There was no harm to the patient.Clarification has been requested as one of the returned products differs from that which was reported by the customer.This is the second of two reports for this case.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable info becomes available.Clarification has been requested as the returned product differs from that which was reported by the customer.(b)(4).

• Brand Name: ILLUMINATED FLEX CURVED LASER PROBE, 25GA
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3949194
• MDR Text Key: 4533288
• Report Number: 2028159-2014-00812
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065751593
• Device Catalogue Number: 8065751593
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TOTAL PLUS PAK, 25+ 5000 CUTS PER MINUTE STD
• Patient Age: 45 YR