MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK; UNIT, PHACOFRAGMENTATION

Model Number BL5115-4

Device Problem Particulates (1451)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation ongoing.

Event Description

The user facility reported a small piece of unidentified plastic or metal from the pack presenting in the anterior chamber during surgery.The surgeon removed the piece and saved it for return.There was no patient injury.

Manufacturer Narrative

The evaluation was completed.One pack assembly and an i/a handpiece were returned in a plastic zip-lock bag.The original packaging was not received.The part number and lot number cannot be verified or determined.However, the pack is an elite anterior pack.The assembly was dirty with fluid in the lines and a small amount in the collection cassette.The needle on the i/a handpiece was bent.The needle wrench and a purple needle tip was returned in a small plastic specimen cup.One grey colored particle was found taped to the underside of the cap of the specimen cup.The particle was squishy and has a "rubbery" texture.It was approximately 1108 x 1906 microns in size.The particle does not have a metallic appearance.This particle will be sent to the lab for analysis.A lot number was not provided; therefore, the sterilization and lot history records could not be reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.

Manufacturer Narrative

Eds analysis indicated the grey particle consists primarily of carbon and silicon.Lesser concentrations of magnesium, oxygen, chlorine, titanium, sodium, potassium, sulfur, and aluminum where also detected.This is consistent with organic material with mineral fillers.The grey particle was analyzed using a fourier transform infrared (ftr) spectrometer.The ftir analysis of the grey particle produced a spectrum consistent with that of a combination of silicone rubber and polyisobutylene.Lab report indicates material is consistent with silicone rubber and polyisobutylene.A stopper used in non-patient application to plug the collection cassette when it is removed at completion of the procedure is composed of a butyl rubber material, but this is not in the fluid path, and it is unknown how this material could have been involved in any patient contact.This investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11273997
• MDR Text Key: 249128336
• Report Number: 0001920664-2021-00008
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL5115-4
• Device Catalogue Number: BL5115-4
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/08/2021; 03/31/2021
• Supplement Dates FDA Received: 03/30/2021; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1