MAUDE Adverse Event Report: RAYNER INRAOCULAR LENSES LIMITED SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR; MSS - DISPOSABLE INJECTOR

Model Number R-INJ-04

Device Problems Detachment Of Device Component (1104); Delivery System Failure (2905)

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.For further information please refer to rayner intraocular lenses limited's mdr 9611165-2014-00067.

Manufacturer Narrative

Rayner intraocular lenses limited reports the following findings: 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 specification 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 (b)(4).

• Brand Name: SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR
• Type of Device: MSS - DISPOSABLE INJECTOR
• Manufacturer (Section D): RAYNER INRAOCULAR LENSES LIMITED; hove ; UK
• MDR Report Key: 4120868
• MDR Text Key: 4921286
• Report Number: 3003563511-2014-00067
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2014,09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Distributor Facility Aware Date: 09/19/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1