MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LTD. SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR; MSS - DISPOSABLE INJECTOR

Model Number R-INJ-04

Device Problems Bent (1059); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Rayner intraocular lenses limited received notification from a (b)(6) healthcare facility of an event that occurred during use of a single use soft-tipped disposable injector (model: r-inj-04).The hospital reports that the plunger bent and that the tip came off into the incision as the lens was being injected into the eye.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The healthcare professional reports that the tip was "easily removed from the incision with no adverse effects." the healthcare professional discontinued use of the r-inj-04 injector.The procedure was able to be completed successfully with a back-up device in the original planned surgery session.The plunger tip detaching itself from the injector suggests that significant pressure may have been applied to the plunger during injection.Our review of production records for the r-inj-04 injector batch b119 showed that all manufacturing and quality checks were conducted with successful results.All injectors released for distribution from this batch were within tolerance, met spec criteria and were without defects.A review of existing vigilance data from the month of manufacture of the r-inj-04 injector (february 2011) was carried out in order to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the r-inj-04 injector batch b119.The r-inj-04 injector was returned to rayner on (b)(4) 2014.The injector has been sterilized and is awaiting inspection.The results of the device inspection performed will be provided in a follow-up report.

• Brand Name: SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR
• Type of Device: MSS - DISPOSABLE INJECTOR
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LTD.; hove ; UK
• Manufacturer Contact: jodi neal ; sackville rd.; 1-2 sackville trading estate; hove, east sussex BN3 7-AN ; UK BN3 7AN ; 1273205401
• MDR Report Key: 4122207
• MDR Text Key: 15805017
• Report Number: 9611165-2014-00067
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: R-INJ-04
• Device Catalogue Number: R-INJ-04
• Device Lot Number: B119
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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