MAUDE Adverse Event Report: BAUSCH + LOMB, INC PHACO ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number DP5501

Device Problem Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.See related 0001920664-2022-00076 and 0001920664-2022-00077.

Event Description

A user facility in (b)(6) reported that during a phacoemulsification (phaco) procedure, the surgeon inserted the phaco handpiece into the eye.When they started performing sculpt and chop, they noticed a white material flowing out from the left irrigating port.The surgeon immediately stopped phaco and removed the ¿unknown white material.¿ it was reported there was no adverse effect on the patient.

Manufacturer Narrative

Correction: hg, type of investigation, 4114.One white particle was returned in a plastic specimen cup.No other products were returned with the particle.It cannot be determined from which device the particle came.The particle is white in color, visible to the unaided eye, and is soft, and pliable.Microscopic examination was performed and found that the particle is fibrous and has the appearance of a flattened-out wad of fiber-like material which is similar in appearance to a cotton swab tip.The particle is curled up on one end, and measured approximately 1,954 microns long, 175 microns thick, and 1,373 microns wide.This particle will be sent to an outside lab for analysis.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 of the particle indicated that the particle consists primarily of carbon, calcium, and oxygen.Lesser concentrations of chlorine, sodium, sulfur, and potassium were also detected.This is consistent with organic material, saline residue, and mineral deposits.The ftir analysis of the particle sample produced a spectrum consistent with that of cellulose.The lab analysis of the particle indicated the material was primarily cellulose with lesser amounts of saline residue, organic material and mineral deposits, none of which are in used in the manufacture of the reported device.The most probable root cause is unknown.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.The investigation is complete.See related 0001920664-2022-00076 and 0001920664-2022-00077.

• Brand Name: PHACO ACCESSORY PACK
• Type of Device: 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 blv; st. louis, MO 63122
• MDR Report Key: 14521875
• MDR Text Key: 293000573
• Report Number: 0001920664-2022-00075
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K961831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DP5501
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2022
• 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
• Treatment: MICROFLOW NEEDLE, ADAPTIVE FLUIDICS BASIC PK