MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS MICRO INCISION VACUUM PACK; UNIT, PHACOFRAGMENTATION

Model Number BL5113

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problems Eye Injury (1845); Eye Burn (2523)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

The stellaris micro incision vacuum pack has been requested for evaluation however it has not yet been received.Sterilization and lot history records were reviewed and no exceptions were found.A technical service technician went to the facility to service the stellaris unit.Balanced salt solution was found inside the unit.The unit was dried, cleaned and tested and released for surgery.The device history records were reviewed and no exceptions were found.

Event Description

During a cataract surgery there was a loss of irrigation resulting in a corneal burn due to the ultrasound heat.No treatment was required for the burn.The doctor stated the patient should recover within four months.

• Brand Name: STELLARIS MICRO INCISION VACUUM PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 7635503
• MDR Text Key: 112240099
• Report Number: 0001920664-2018-00073
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)MISSING_UPC(17)190727
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2019
• Device Model Number: BL5113
• Device Lot Number: W1247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT
• Patient Outcome(s): Other