MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED SUPERFLEX ASPHERIC; HQL - INTRAOCULAR LENS

Model Number 920H

Device Problems Difficult to Insert (1316); Delivery System Failure (2905); Device Damaged by Another Device (2915)

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

Event Date 03/01/2015

Event Type  malfunction  

Event Description

Rayner intraocular lenses limited received notification from a (b)(6) healthcare facility of an event that occurred during implantation of a superflex aspheric 920h iol.The event description provided by the healthcare facility states "on injection, haptic got caught between nozzle and plunger and so part of haptic was left hanging out the limbus".For further information please see rayner intraocular lenses limited's mdr 9611165-2015-00016.

Manufacturer Narrative

The testing performed indicates that the injector problem may have occurred as the flap fixing is missing from the injector.This damage is likely to have occurred during manufacture; however, it is not possible to confirm at what stage of the manufacturing process the damage may have occurred.A review of existing vigilance data from the month of manufacture of the superflex aspheric 920h iol (september 2013) was carried out in order to determine if any trends existed.This review confirmed that no other incidents, of any type, have been received against the superflex aspheric 920h iol batch 093e51753 or the injector batch associated with this case report.

• Brand Name: SUPERFLEX ASPHERIC
• Type of Device: HQL - INTRAOCULAR LENS
• 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: 4792788
• MDR Text Key: 5818191
• Report Number: 3003563511-2015-00017
• Device Sequence Number: 1
• Product Code: HQL
• 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: 03/11/2015

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: 09/30/2018
• Device Model Number: 920H
• Device Catalogue Number: 920H
• Device Lot Number: 09E51753
• Other Device ID Number: POWER: +7.0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2015
• Distributor Facility Aware Date: 03/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1