MAUDE Adverse Event Report: BAUSCH + LOMB 23GA IRRIGATION HANDPIECE SMOOTH; HAND HELD SURGICAL INSTRUMENT

Model Number 85807S

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

The device manufacturing records were reviewed and no deviation or issue detected.Lot was manufactured according to specifications.Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A report was received from a user facility in (b)(6) indicating that the surgeon found blue debris in the eye during the procedure.He was able to remove the particle from the eye without any reported impact or injury to the patient.

Manufacturer Narrative

One small tube containing a small debris was returned for evaluation.The instrument involved in the event was not returned.The debris was sent to a laboratory for analysis to determine the nature of the debris.The results of chemical analysis indicated that the composition of the debris is a sort of paraffin.Paraffin is not used in the production process of the instrument.The origin of the debris cannot be determined.

• Brand Name: 23GA IRRIGATION HANDPIECE SMOOTH
• Type of Device: HAND HELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; bausch + lomb; im schumachergewann 4; heidelberg 69123 ; GM 69123
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618
• MDR Report Key: 5431251
• MDR Text Key: 38048739
• Report Number: 0001920664-2016-00035
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 85807S
• Device Lot Number: FS15071133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• 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