MAUDE Adverse Event Report: BAUSCH + LOMB, INC STELLARIS MICRO INCISION VACUUM PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL3118
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.The product was not returned so we are unable to investigate for the root cause.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 required.If the product is returned at a later date, this investigation will be re-opened.At this time, the investigation is considered complete.
Event or Problem Description
A user facility in (b)(6) reports that during surgery, the surgeon found a microscopic transparent filament in the patient¿s eye.The surgeon asserts that the transparent filament came from the sterile medical device.The filament was extracted.The patient outcome is unknown.
Additional Manufacturer Narrative
One small plastic vial/specimen cup was returned in a plastic bag.None of the pack components were received.The part number and lot number of the pack cannot be determined.The vial contains an unknown fluid and a light colored, transparent, long, particle can be seen floating in the fluid inside of the vial.The particle is tube-like in shape, and is similar to a straw in that it appears to be hollow in the middle.The particle is flexible and easily damaged.The bend in the straw-like particle was caused from the forceps that were used to retrieve it from the fluid.The particle is approximately 1119 microns long by 21 microns wide.This particle was sent to an external laboratory for analysis.The analysis of the particle indicated it consisted primarily of polyamide 6 (nylon 6) with lesser concentrations of titanium dioxide pigment.The particle sample was microscopically examined, photographed, and measured using a camera-equipped optical stereo microscope.The sample was analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope(sem) and a fourier transform infrared (ftir) spectrometer.Eds analysis indicated that the particle consists primarily of carbon and oxygen.Lesser concentrations of titanium were also detected.This is consistent with organic material and titanium dioxide pigment.The ftir analysis of the particle produced a spectrum consistent with that of polyamide 6 (pa6).Laboratory analysis indicates the particle consists primarily of polyamide 6 (nylon 6) with lesser concentrations of titanium dioxide pigment.These materials are not used in the bl3118 product.The source of the returned particle cannot be determined.Therefore the root cause is unknown/inconclusive.It was reported that there were no clinical consequences.The investigation is complete.

• Brand Name: STELLARIS MICRO INCISION VACUUM PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122
• MDR Report Key: 14027995
• Report Number: 0001920664-2022-00046
• Device Sequence Number: 2570093
• Product Code: HQC
• UDI-Device Identifier: 10757770057389
• UDI-Public: (01)10757770057389(17)261016
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: BL3118
• Device Catalogue Number: BL3118
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown