MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, rayner intraocular lenses limited received notification from a us healthcare facility that a lens subject to recall (ref.3012304651-05/17/2022-001-r) had been implanted.Post-operatively, the patient has presented with a refractive error.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The rayone emv rao200e iol was implanted on (b)(6) 2022.Post-operatively, the patient has presented with a refractive error.Rayner has contacted the healthcare facility to obtain additional information on the patient outcome.The implanted lens is subject to a voluntary recall initiated by rayner on (b)(6) 2022.The recall reference assigned by fda is (b)(4)-05/17/2022-001-r.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The rayone emv rao200e iol was implanted on (b)(6) 2022.Post-operatively, the patient has presented with a refractive error.The follow-up information received identified that the patient would undergo a lens exchange procedure to correct their visual outcome.The date of the lens exchange procedure has not been reported to rayner by the healthcare facility.The implanted lens is subject to a voluntary recall initiated by rayner on (b)(6) 2022.The recall reference assigned by fda is (b)(4).
Event or Problem Description
On (b)(6) 2022, rayner intraocular lenses limited received notification from a us healthcare facility that a lens subject to recall (ref.(b)(4)) had been implanted.Post-operatively, the patient has presented with a refractive error.

• Brand Name: RAYONE EMV
• Common Device Name: 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: 14494992
• Report Number: 3012304651-2022-00029
• Device Sequence Number: 12231079
• Product Code: HQL
• UDI-Device Identifier: 05029867006685
• UDI-Public: (01)05029867006685
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 012183745
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown