MAUDE Adverse Event Report: BAUSCH + LOMB MILLENNIUM MICROSURGICAL SYSTEM; INSTRUMENT, VITREOUS ASPIRTION & CUTTING, AC POWER

Model Number CX6000

Device Problem Insufficient Information (3190)

Patient Problems Corneal Edema (1791); Purulent Discharge (1812); Inflammation (1932)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.The device history records were reviewed and found test procedure document no.P-118-007 rev.Q, met specifications.The lot history, trend analysis, risk analysis, and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further information is available for this event.No corrective action required.The investigation is complete.

Event Description

The user facility in (b)(6) reported the patient received left eye phacoemulsification and intraocular lens implantation under local anesthesia.The surgery was completed with no issues.During the surgery, the patient was implanted with med + 21 spherical lens.The patient returned to the ward after the operation.There was no special reaction on the first postoperative day, and the patient was discharged for follow-up.On april 16, the patient was found to have membranous exudation on the surface of the intraocular lens in the left eye during outpatient follow-up and was given anti-inflammatory treatment for corneal edema and iridocyclitis.This event was reported to (b)(6) national medical device adverse events reporting system by (b)(6) hospital.

• Brand Name: MILLENNIUM MICROSURGICAL SYSTEM
• Type of Device: INSTRUMENT, VITREOUS ASPIRTION & CUTTING, AC POWER
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 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: 12067943
• MDR Text Key: 261779082
• Report Number: 0001920664-2021-00078
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K961310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CX6000
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR