MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
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 healthcare facility in correspondence with rayner has stated "at this time, dr.Bergstrom wants to continue to follow the patient.The patient has a slight refractive error but he does not feel a lens exchange is needed.He will see the patient again in a week".The implanted lens is subject to a voluntary recall initiated by rayner on (b)(6) 2022.The recall reference assigned by fda is 3012304651-05/17/2022-001-r.
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.The healthcare facility in correspondence with rayner has stated "at this time, dr.(b)(6)wants to continue to follow the patient.The patient has a slight refractive error but he does not feel a lens exchange is needed.He will see the patient again in a week".The follow-up information received from the healthcare facility identified that the patient would undergo a photorefractive keratectomy (prk) in (b)(6) 2022 to correct their visual outcome.The implanted lens is subject to a voluntary recall initiated by rayner on 17th may 2022.The recall reference assigned by fda is (b)(4).
Event or Problem Description
On 16th may 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: 14461440
• Report Number: 3012304651-2022-00025
• Device Sequence Number: 4482662
• Product Code: HQL
• UDI-Device Identifier: 05029867006685
• UDI-Public: (01)05029867006685
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/20/2022
• 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