MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED NOT AVAILABLE; HQL - INTRAOCULAR LENS

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/28/2015

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 an unspecified rayner device.The event description provided by the healthcare facility states "lens loaded perfectly but when inserted part of haptic were torn apart".For further information please refer to rayner's mdr 9611165-2015-00019.

• Brand Name: NOT AVAILABLE
• 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: 4792789
• MDR Text Key: 5854070
• Report Number: 3003563511-2015-00020
• Device Sequence Number: 1
• Product Code: MSS
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2015
• Distributor Facility Aware Date: 03/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1