MAUDE Adverse Event Report: BAUSCH + LOMB, GMBH MICS SIL I/A HDP 45° STELL; UNIT, PHACOFRAGMENTATION

Model Number 85915ST EACH

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/25/2022

Event Type  malfunction  

Event Description

A user facility in the united kingdom reports that the an i/a tip broke off in patient's eye.The facility had to open and use a forcep to retrieve the foreign body.Surgery time increased by at least 20 mins.Patient had to be seen the next day for an extra check.

Manufacturer Narrative

The device has been requested, but not yet received for evaluation.The investigation is underway.

Manufacturer Narrative

The design history file was reviewed; no deviations or issues were detected.The lot was manufactured according to specification.The complaint sample was returned to the manufacturing site in heidelberg.The sample was loose in a bl5114 stellaris premium vacuum phaco pack with no transport protection.The broken off piece of the silicone sleeve was returned as well.The visual inspection of the sample confirmed that the silicone sleeve was severely damaged and the tip was completely broken off.Therefore, the reported problem was duplicated.An instrument in this condition cannot only not function, but also would not have passed the final quality check.Therefore, the damage occurred during surgery due to applying to much pressure on the sleeve.The strong rubbing of the sleeve on the membrane then led to the tear.Therefore, the root cause was determined to be user error.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 required.The investigation is complete.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, GMBH; im schuhmachergewann 4; heidelberg 69123 ; GM 69123
• Manufacturer (Section G): BAUSCH + LOMB, GMBH; im schuhmachergewann 4; heidelberg 69123 ; GM 69123
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 636226-322
• MDR Report Key: 15275778
• MDR Text Key: 299481288
• Report Number: 0001920664-2022-00112
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85915ST EACH
• Device Lot Number: FS22049484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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