MAUDE Adverse Event Report: ALCON LABORATORIES, INC. IRRIGATION AND ASPIRATION HANDPIECE; UNIT, PHACOFRAGMENTATION

Lot Number 153527M

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2022

Event Type  Injury  

Event Description

"s: small sharp ferric brown fragment went in pt's eye during the irrigation and aspiration procedure b: pt was having left cataract surgery done a: surgeon removed fragment without incident r: took down all the information to the disposable hand piece that is in question.Bss bag lot # 114j2, exp: 01/2025, centurion machine tubing - lot # 2525759h, manufacture date 10/19/2021 irrigation and aspiration handpiece - 153527m." fda safety report id # (b)(4).

• Brand Name: IRRIGATION AND ASPIRATION HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 14514617
• MDR Text Key: 292829059
• Report Number: MW5109941
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2022

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
• Device Operator: Health Professional
• Device Lot Number: 153527M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSS BAG LOT # 114J2, EXP: "01/202"; CENTURION MACHINE TUBING - LOT # 2525759H, MANUFACTURE DATE 10/19/2021
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White