MAUDE Adverse Event Report: BAUSCH + LOMB 25GA STELLARIS PC VITRECTOMY PROBE; UNIT, PHACOFRAGMENTATION

Model Number BL5625S

Device Problem Suction Failure (4039)

Patient Problems Intraocular Pressure Increased (1937); Retinal Detachment (2047); Capsular Bag Tear (2639)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

The product is not available for return so unable to investigate further for the root cause.Manufacturing and sterilization records were reviewed and found to be acceptable.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.

Event Description

The user facility in france reported that during cataract surgery, an anterior vitrectomy was performed, and the vitrectomy probe failed to aspirate the vitreous.The surgeon reported there were no abnormality before starting the surgery nor at the beginning of the intervention.The surgeon pushed the vitreous with an ophthalmic visco-surgical device allowing the vitreous to be pushed back as far as possible towards the back of the eye.The position of vitreous in the anterior chamber induced an immediate consequence of pupil deformation, poor visual acuity recovery, significant retinal detachment because the vitreous which is still attached to the retina, pulls on it as it passes through the back of the eye to the anterior chamber following iatrogenic posterior capsular rupture.Moreover, the stagnation of the vitreous in the irido-corneal angle in post-op induced an increased intraocular pressure.The surgery lasted approximately one (1) hour, without additional anesthesia.There was an increase in the dose of local corticosteroids post-op as well as subconjunctival injection of celestene the first two days after surgery.On day two post-op, the surgeon sent the patient to the ophthalmological emergency room for revision surgery with anterior vitrectomy because the presence of vitreous in the anterior chamber was too high.

Event Description

Iop post-surgery at d1 was 28mmhg, it was treated with diamox (acetazolamid) 250mg x 3 per day via oral route and 1 capsule of diffu k (potassium chloride) in the evening.The patient was sent by surgeon to another hcf for revision surgery.

Manufacturer Narrative

Additional information added to b5.

• Brand Name: 25GA STELLARIS PC VITRECTOMY PROBE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree ct. industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17334194
• MDR Text Key: 319185385
• Report Number: 0001920664-2023-70070
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770059843
• UDI-Public: (01)00757770059843(17)231024(10)X1863
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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 Expiration Date: 10/24/2023
• Device Model Number: BL5625S
• Device Lot Number: X1863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1