MAUDE Adverse Event Report: BAUSCH + LOMB, INC. STELLARIS POSTERIOR COMBINED SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL1433

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

The device history was reviewed and found to meet manufacturing specification.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported during surgery the equipment suddenly stopped when the cassette ejected from the stellaris unit.The cassette was inserted back into the stellaris and the surgery resumed.The procedure was aborted and not completed according to plan and timeline.Additional information has been requested.

Manufacturer Narrative

The product was not returned for evaluation, but it was evaluated by the field service engineer on site.It was determined that the problem is the pcb of the pfm module, but this part cannot be replaced separately.Consequently, the module was changed.Therefore, the root cause was determined to be a component issue.This investigation is complete.

Manufacturer Narrative

The product was not returned for evaluation.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is complete.

Manufacturer Narrative

Correction: d4: pfm02513.

• Brand Name: STELLARIS POSTERIOR COMBINED SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; rochester NY 14609
• MDR Report Key: 9565721
• MDR Text Key: 177416055
• Report Number: 0001920664-2020-00001
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL1433
• Device Catalogue Number: BL1433
• Device Lot Number: SPC02214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention