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

Model Number R-INJ-04

Device Problems Detachment Of Device Component (1104); Device Handling Problem (3265)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Event Description

Rayner intraocular lenses limited received notification from its distributor in cyprus of an event that occurred during use of a single use soft-tipped disposable injector (model: r-inj-04).The event description as provided by the distributor states "trying to open the moving flap of the injector, in order to load the iol, the flap got detached from the system".For further information please refer to rayner's mdr 9611165-2014-00077.

Manufacturer Narrative

Rayner intraocular lenses limited reports the following investigation findings; our review of production records for the r-inj-04 injector batch b475 showed that all manufacturing and quality checks were conducted with successful results.All injectors released for distribution from this batch met acceptance criteria and were without defects.A review of existing vigilance data from the month of manufacture of the r-inj-04 injector (january 2014) 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 INTRAOCULAR LENSES LIMITED; hove ; UK
• MDR Report Key: 4290523
• MDR Text Key: 20267601
• Report Number: 3003563511-2014-00077
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: CY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/12/2014,10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: R-INJ-04
• Device Catalogue Number: R-INJ-04
• Device Lot Number: B475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2014
• Distributor Facility Aware Date: 11/12/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention