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

Model Number R-INJ-04

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Event Description

Rayner intraocular lenses limited received info from its distributor in (b)(6) 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 gor detached from the system.".

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The injection system was discarded from use by the healthcare professional following flap detachment.The incident of flap detachment had no adverse effect to the pt.The healthcare facility has confirmed that they were able to complete the procedure in the original planned surgery session.The healthcare professional reports that another iol of the same power was not available and states ".An iol with a power of 0.5d increments more" was implanted.As a result of the difference in iol power the pt's vision is reported to have been affected.The r-inj-04 injector is being returned to rayner for inspection.The results of the device inspection performed will be provided in a f/u report.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 b475.

• 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: jodie neal ; sackville rd; 1-2 sackville trading estate; hove, east sussex BN3 7-AN ; UK BN3 7AN ; 1273205401
• MDR Report Key: 4280183
• MDR Text Key: 5294585
• Report Number: 9611165-2014-00077
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: CY
• PMA/PMN Number: K062612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• 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
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Required Intervention