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 Red Eye(s) (2038)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that 8 days post iol implantation the patient presented with redness of the eye.The patient was prescribed antibiotics; however, their symptoms did not resolve.The patient was then prescriped methylprednisolone; however, this has also been unsuccessful in resolving their symptoms.Every batch of iols manufactured by rayner are tested for endotoxin and bioburden.Rayner's endotoxin acceptable tolerances are derived from bs en iso 11979-08 (2017) ophthalmic implants - intraocular lenses part 8 fundamental requirements.We have set our own limits for bioburden as there is no standard that prescribes acceptable limits.Batches are only released for distribution if the endotoxin and bioburden results are within tolerance of their respective limits which makes a rayner microbiological issue for these incidents of eye redness very unlikely.The cause of the post-operative redness of the eye has not been established.There is currently insufficient information available.No lot number has been provided to rayner to date.Rayner has requested additional information from its distributor in indonesia to facilitate further investigation of the event, including whether or not the healthcare facility uses reusable surgical instruments or single use instruments.

Event Description

On (b)(6) 2022, rayner intraocular lenses limited received notification from its indonesian distributor of an event that occurred following implantation of rayone emv rao200e.The event description provided states that 8 days post-operatively the patient presented with eye redness requiring medication.

• Brand Name: RAYONE EMV
• Type of Device: RAYONE
• 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: 15275357
• MDR Text Key: 298620510
• Report Number: 3012304651-2022-00052
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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
• Device Lot Number: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• 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