MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER SLIT LAMP; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Catalog Number 8065740982

Device Problem Power Problem (3010)

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

Event Type  malfunction  

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 information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that the light of the lamp was low and the power of the laser was low.Additional information has been requested.

Manufacturer Narrative

The company service representative examined the system and slit lamp cable.The illumination issue was caused by dirty optics.The company service representative cleaned the optics to resolve the issue.The company service representative could not replicate the reported laser event.The system was then tested and met all product specifications.The slit lamp serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.The root cause of the ¿illumination¿ can be attributed to the dirty optics.The root cause of the reported event of ¿laser low/no power¿ could not be determined as the product was found to meet specifications.The manufacturer internal reference number is: (b)(4).

• Brand Name: SLIT LAMP
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 9750303
• MDR Text Key: 184269928
• Report Number: 2028159-2020-00139
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• PMA/PMN Number: K101182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065740982
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUREPOINT LASER