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

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

An ophthalmic surgeon reported that the intraocular pressure was unstable during a vitreoretinal procedure.The issue was resolved by replacing the product.There was no harm to the patient.Additional information has been requested.

Manufacturer Narrative

A product sample was requested; however, it has not yet been received by the manufacturing site.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).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4507959
• MDR Text Key: 21450320
• Report Number: 2028159-2015-00203
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: 3.00.61
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: VALVED, STANDARD; TOTAL PLUS PAKS, 25 GAUGE, 5000 CUTS PER MINUTE,