MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS IV POLE; UNIT, PHACOFRAGMENTATION

Model Number BL2340

Device Problems Insufficient Flow or Under Infusion (2182); Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); Zonular Dehiscence (2698)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The iv pole was inspected by our field service engineer.The examination found dirt rings deposited on the iv pole which were preventing it from rising.The iv pole was thoroughly cleaned and tested, all movements were normal.

Event Description

A report received from a user facility in the (b)(4) stated that the i/v pole stuck in home position failing to raise to the programmed setting of 120 cm for segment removal.The anterior chamber was insufficiently filled with bss and resulted in damage to the capsular bag and zonules.At the post-op visit, the patient was fine, the vision improved and no problems reported.

• Brand Name: STELLARIS IV POLE
• 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: 6789354
• MDR Text Key: 82555408
• Report Number: 0001920664-2017-00261
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL2340
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2017
• 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
• Patient Outcome(s): Other