MAUDE Adverse Event Report: BAUSCH + LOMB I/A HANDPIECE45 ANG; UNIT, PHACOFRAGMENTATION

Model Number 85784ST

Device Problem Crack (1135)

Patient Problem Capsular Bag Tear (2639)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The user facility in the united kingdom reported the metal tip on the irrigation/aspiration handpiece cracked and caused a posterior capsular rent (pcr).There was no patient impact or medical intervention reported.

Event Description

The user facility in the united kingdom reported the metal tip on the irrigation/aspiration handpiece cracked and caused a posterior capsular rupture (pcr).Additional information: it was a wound hole, which remained stable.Vitrectomy was done and iol still in the bag.Outcome is very good to the best of surgeons knowledge.

Manufacturer Narrative

Correction: b5: event changed from posterior capsular rent to posterior capsular rupture.D4: udi changed from (b)(4) to (b)(4).Additional information: b5: description and patient outcome added.

Manufacturer Narrative

The device was returned and evaluated.Visual inspection confirmed the damage as the metal tip of the needle was completely broken at a 90° degree angle.Pieces of membrane were also visible.Despite the reported problem having been duplicated and confirmed, the root cause of the damage could not be determined.A review of the device history record found no conconformities or anomalies related to this complaint.The lot history, trend analysis and risk analysis review were considered acceptable, with the product performing within anticipated rates.

• Brand Name: I/A HANDPIECE45 ANG
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; lilienthalstr. 16, 18; eppelheim NY 69214 ; GM 69214
• Manufacturer (Section G): BAUSCH + LOMB GMBH; lilienthalstr. 16, 18; eppelheim 69214 ; GM 69214
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18639456
• MDR Text Key: 334510838
• Report Number: 0001920664-2024-70015
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85784ST
• Device Lot Number: FS23061036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/28/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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