MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR INFINITI VISION SYSTEM OZIL; PHACOFRAGMENTATION SYSTEM

Model Number INFINITI OZIL JAPAN

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Intraocular Pressure, Delayed, Uncontrolled (1936); No Consequences Or Impact To Patient (2199)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

A surgeon reported that during cataract surgery, the irrigation tubing detached from the phaco handpiece.As a result, the patient's eye became soft.However, the case was continued, and there was no harm to the patient.Additional information has been requested.

Manufacturer Narrative

A sample is expected to return for in-house evaluation.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: INFINITI VISION SYSTEM OZIL
• Type of Device: PHACOFRAGMENTATION SYSTEM
• Manufacturer (Section D): ALCON - IRVINE TECHNOLOGY CTR; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON - IRVINE TECHNOLOGY CTR; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 3915582
• MDR Text Key: 4514042
• Report Number: 2028159-2014-01118
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082845
• 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: 05/14/2014

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: INFINITI OZIL JAPAN
• Device Catalogue Number: 8065751143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 06/11/2014
• 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: ASSY; SHIP; HANDPIECE OZIL