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

Model Number WITH LASER

Device Problems Reflux within Device (1522); Detachment of Device or Device Component (2907)

Patient Problems Retinal Injury (2048); Retinal Tear (2050)

Event Date 05/10/2014

Event Type  Injury  

Event Description

A surgeon reported that during a macular zone revision procedure, the compressor sounded abnormal, a system message displayed, and then the cannula attached to the extrusion line shot off and injured a patient's macula.Add'l info rec'd via returned questionnaire.The surgeon indicated during simultaneous silicone infusion and aspiration of "pfos", in the left eye, reflux occurred in the aspiration port; as a result of this event, the 25 gauge aspiration cannula came off the connector and "digged into the eyeground and harmed the foveolar area of the retina".The outcome was a retinal tear.In the surgeon's opinion, "the connector of the cannula should be more secure (tapped)".

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 add'l reportable info becomes available.(b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• 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: 3884072
• MDR Text Key: 4423806
• Report Number: 2028159-2014-01052
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 05/26/2014

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: WITH LASER
• Device Catalogue Number: 8065751145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2014
• Initial Date FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 75