MAUDE Adverse Event Report: BAUSCH & LOMB STELLARIS VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL11110

Device Problems Loss of Threshold (1633); Device Issue (2379); Device Operational Issue (2914)

Patient Problems Iatrogenic lesion (1922); Pain (1994)

Event Date 06/15/2015

Event Type  Injury  

Event Description

A report was received from a user facility in (b)(6) stating that: surgeon started a cataract surgery by priming the phacoemulsificator.The priming occurred without incident and the machine closed the step as usual by saying thru the loudspeaker "priming finished".After having performed sterilization and installing the surgical drape he started the surgery by performing the rhexis and the hydrodissection of the crystalline lens.For the following surgical step he took the phacoemulsificator handpiece and before introducing it into the eye he tested the machine in a vial with irrigation solution as he does for each surgery.The phaco machine did not deliver ultra sounds.He re-primed the machine which displayed an error message.He checked if the needle was correctly screwed and it was.He changed the cassette and used another handpiece.The machine primed correctly but did not deliver ultra sounds.He then primed several times the phacoemulsificator and an error message was displayed about one or two times.He stopped the machine and restarted the phaco machine without success.Surgery having started it was imperative to finish it.So he contacted another ophthalmologist from different site which could take care of the pt.Due to inflammation the second surgery was painful and could not be performed without general anesthesia which required pt hospitalization.Clinical consequences were the stopping of the surgical procedure and the necessity of transferring the pt to a different site for completing the surgery in an emergency.The surgery was completed on the (b)(6) and the pt has since recovered without further medical attention needed.

Manufacturer Narrative

The system has not yet been received for eval.

Manufacturer Narrative

No external visual defects were noted.A functional test was performed.The module did not display any error codes and performed as intended.However, upon opening the module it was discovered that the c6 capacitor is missing from the 102-002-442a printed circuit board.There is evidence of scorch and smoke markings on the board.Based on functional testing and component failure analysis of the module, the engineering analysis concluded that the root cause of the reported problem is the failure of the 100uf tantalum capacitor at the (c6) location on the 102002442a pcb with serial number (b)(6).H3.Not evaluated reason: placeholder.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH & LOMB; rochester NY 14609
• Manufacturer Contact: sharon spencer, dir qlty assuran ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4955787
• MDR Text Key: 6190591
• Report Number: 1920664-2015-00131
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL11110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other