MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number RAO200E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intraocular Infection (1933)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(6) has been allocated to this case by rayner.The verbatim report received from the patient states "i had cataract surgery at the end of july beginning of august.For each eye i purchased a $500 upgraded lens.Starting in september, my eyes were draining mucus and liquids making it difficult it drive.I did not go to so cal eye in a timely manner.But have been there 3 times, recently.They have no idea what is causing this problem".Rayner as a medical device manufacturer cannot comment on individual cases or provide medical advice directly to members of the public.The patient has been instructed to contact a medical professional.Rayner is attempting to make direct contact with the implantating healthcare facility in order to facilitate further investigation.Every rayner lens batch is subject to endotoxin and bioburden testing prior to being approved for release and it is therefore very unlikely that the reaction experienced by the patient post-operatively is related to the lens.Our endotoxin results are derived from bs en iso 11979-08 (2017) ophthalmic implants - intraocular lenses part 8 fundamental requirements.We have set our own bioburden limits internally as there is no standard that prescribes acceptable limits.

Event Description

On 24th april 2022, rayner intraocular lenses limited received notiification from a patient that following implantation of a rayone emv rao200e they have experienced an intraocular infection.

• Brand Name: RAYONE EMV
• Type of Device: RAYONE EMV
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• Manufacturer (Section G): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• Manufacturer Contact: jodie neal ; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 -8AQ ; UK BN14 8AQ
• MDR Report Key: 14249872
• MDR Text Key: 299457231
• Report Number: 3012304651-2022-00022
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Date Manufacturer Received: 04/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female