MAUDE Adverse Event Report: BAUSCH + LOMB MCPHERSONS ROTATOR; OPHTHALMIC INSTRUMENT

Model Number P505

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

The hospital reported that the instrument involved in this event was from "(b)(4)".However, the review of our records, systems and catalogs did not find any information regarding the manufacturing of this instrument.We are reporting this event base on the information provided in the report by the (b)(6).

Event Description

We were notified by the (b)(6) of an incident reported to them by (b)(6) hospital in (b)(6).The report stated that while the instrument was being used, a small part of the tip broke off in the patient's eye.There was no injury to the patient.

• Brand Name: MCPHERSONS ROTATOR
• Type of Device: OPHTHALMIC INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st louis, MO 63122 ; 6362263220
• MDR Report Key: 7899314
• MDR Text Key: 121722203
• Report Number: 0001920664-2018-00127
• Device Sequence Number: 1
• Product Code: HMF
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P505
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1