MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problems Device Inoperable (1663); Output below Specifications (3004)

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.(b)(4).

Event Description

A customer reported experiencing cut rate not at full power, light kept fading even after turning it up, fluid air exchange not working, and extrusion was weak.

Manufacturer Narrative

The system was examined and the reported events were replicated.The illuminator was replaced and returned for evaluation.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on october 30, 2009.Based on qa assessment, the product met specifications at the time of release.An auxiliary illuminator was received for evaluation.A visual assessment of the returned sample revealed no obvious nonconformity.A known-good lamp was installed into the module, which was then installed into a calibrated system for functional testing.The illumination output was found to be below specifications on both ports.The module was opened and the optics enclosure was exchanged with a known-good part.The module was retested and the illumination output was found to meet specifications.The system was found to meet specifications.The reported ¿probe, vfc, and fax issues cannot be determined conclusively.The root cause of the reported illumination issue can be attributed to a nonconforming optics enclosure was found.However, how or when it became nonconforming cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7350627
• MDR Text Key: 103007690
• Report Number: 2028159-2018-00562
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 380657511501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other