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

Model Number R-INJ-04

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316)

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

Event Type  malfunction  

Event Description

Rayner intraocular lenses limited received notification from a (b)(4) healthcare facility of an event that occurred during use of a single use soft-tipped disposable injector (model: r-inj-04).The event description provided by the healthcare facility states that the operating healthcare professional felt that too much pressure had to be applied to advance the plunger and as a result of the force exerted on the plunger, the cartridge reopened resulting in the haptic tearing.For further information please refer to rayner intraocular lenses limited's mdr 9611165-2015-00013.

Manufacturer Narrative

The healthcare professional followed the ifu and discarded the injector from use.The excessive force that was required to be applied to advance the plunger may indicate that the lens was not positioned correctly in the loading bay prior to the plunger being advanced or that the plunger had not been fully prepared (retracted out of the loading bay) before the lens was loaded.

• Brand Name: SINGLE USE SOFT-TIPPED DISPOSABLE INJECTOR
• Type of Device: MSS - INTRAOCULAR LENS INSERTER
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; hove ; UK
• Manufacturer (Section G): METRO PARK WAREHOUSES, INC.; 6901 stillwell; kansas city MO 64120
• Manufacturer Contact: 6901 stillwell; kansas city, MO 64120
• MDR Report Key: 4792785
• MDR Text Key: 5818188
• Report Number: 3003563511-2015-00014
• 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: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: R-INJ-04
• Device Catalogue Number: R-INJ-04
• Device Lot Number: B620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2015
• Distributor Facility Aware Date: 03/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1