MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER INFINIT VISION SYSTEM OZIL; PHACOFRAGMENTATION SYSTEM

Model Number INFINITI OZIL

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/18/2014

Event Type  Injury  

Event Description

A biomedical technician reported that during a cataract removal with intraocular lens (iol) implant procedure, an "important leakage" of bss (balanced salt solution) was observed at the connection of the bss irrigation tubing with the cassette.The bss bag was changed.There was a rupture and disconnection of the irrigation tubing from the cassette, "with no apparent reason" per the reporter, which lead to depression in the system.As a consequence, capsular bag rupture occurred in the patient's left eye.Additional information has been requested.

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.A root cause has not been identified.(b)(4).

• Brand Name: INFINIT VISION SYSTEM OZIL
• Type of Device: PHACOFRAGMENTATION SYSTEM
• 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: 4020543
• MDR Text Key: 18729499
• Report Number: 2028159-2014-01412
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFINITI OZIL
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CUSTOM PAK; DUOVISC; INTREPID PLUS PAK 0.9MM ULTRA MF 30K
• Patient Outcome(s): Other
• Patient Age: 77 YR