MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number BL3170

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Endophthalmitis (1835); Vitrectomy (2643)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Additional information regarding the event, the device and the patient has been requested.The investigation is ongoing.

Event Description

The user facility in (b)(6) reports 4 cases of endophthalmitis in a month and a half.The 4 cases used 3 different iol brands and different viscoelastic substances.Three of the surgeons used the handpiece and standard custom packs.Additional information regarding the event and patient impact has been requested.

Manufacturer Narrative

A bacteriological sampling of all of handpieces was carried out after sterilization as soon as these cases were declared.Everything came back negative except one handpiece (staphylococcus non aureus).The handpiece is in quarantine and will not be put back into circulation.The investigation is ongoing.

Manufacturer Narrative

Endophthalmitis occurred at post-op day 8 with the patient being hospitalized for several days.The patient presented with infection associated with a very severe inflammatory reaction.Corrective treatment at day zero was intravitreal injection of vancomycin + fortum (ceftazidime).On day 2 another intravitreal antibiotic treatment of vancomycin + fortum (ceftazidime) + celestene(betamethasone).Beginning of local corticoids with dexafree (dexamethason) in eyedrop at day 2 also associated with subconjunctival injections of celestene (betamethasone) every day for a few days.Eyedrop antibiotherapy with vancomycin and fortum (ceftazidime) was received for 5 days.Then antibiotherapy with tobradex eye drop (tobramycin/dexamethason) associated with ciloxan ophthalmological ointment (ciprofloxacin) was received for 10 more days.Two weeks after beginning of treatment a vitrectomy was performed.Surgeon indicated visual recovery 0 4/10.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is necessary.See related reports:0001920664-2020-00158, 0001920664-2020-00159 and 0001920664-2020-00161.

Manufacturer Narrative

One stellaris handpiece, serial number (b)(6) was returned in an opened unknown sterilization pouch.The customer was unable to identify which event (see related reports) this handpiece was used in.Close examination of the returned pouch shows that the pouch and presumably the handpiece have been steam sterilized as the indicators on the bag are brown per the exposure key/instructions.Visual inspection and microscopic examination of the handpiece found no damage.The device history record was reviewed with no anomalies noted.A bacteria testing was performed by the customer after steam sterilization, and it was found that the returned device was tested positive for staph aureus bacteria.An endotoxin test was deemed not necessary since the presence of endotoxins cannot pinpoint when it was introduced into the device.Root cause of endophthalmitis could not be determined due to the condition in which the device was returned.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 is necessary.See related reports:0001920664-2020-00158, 0001920664-2020-00159 and 0001920664-2020-00161.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10906551
• MDR Text Key: 219527764
• Report Number: 0001920664-2020-00160
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: BL3170
• Device Catalogue Number: BL3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/16/2020; 01/15/2021; 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS AND ACCESSORIES, A CUSTOM PACK; TWINVISC,BLUEMIX 180, CT ASPHINA IOL
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR