MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient underwent a secondary surgery to explant the rayone emv rao200e due to refractive issues.The patient underwent implantation of the rayone emv rao200e on (b)(6) 2024 and explantation of the lens was performed on (b)(6) 2024.Within the explantation procedure, the patient received an iol exchange.There are many factors which may influence the post-operative outcome of the patient including but not limited to; incomplete removal of ovd following iol implantation (capsular block/capsular bag distension syndrome), dry eye during biometry measurement, incorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power caused by incorrect biometry readings/calculations (e.G., previous lasik procedure), incorrect power selection (not using optimised a-constants may be a contributory factor in this scenario - surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.), posterior synechiae, irregular capsular bag contraction, patient medical history (e.G., glaucoma, pseudoexfoliation syndrome), lens decentration or dislocation, incorrect or unstable fixation within the capsular bag, post-operative rotation of the lens, lens does not fit anatomy of the eye (e.G., too large or too small), capsulorhexis diameter too large and induced surgical astigmatism.There is insufficient information available currently to establish the nature and/or cause of the reported refractive issues.Rayner is seeking additional information from the reporter via its in-country representatives.Our review of production records for the rayone emv rao200e batch 053216696 showed that ll manufacturing and quality checks were conducted with successful results.All devices released for distribution from this batch were within tolerance, met specification criteria and were without defects.A review of vigilance data confirms that this is an isolated event.No other incidents, of any type, have been received against the rayone emv rao200e batch 053216696.
Event or Problem Description
On 7th june 2024, rayner received notification from a us healthcare facility of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that the lens needed to be explanted in a secondary surgery due to a refractive issue.

• 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: 19603989
• Report Number: 3012304651-2024-00130
• Device Sequence Number: 15283319
• Product Code: HQL
• UDI-Device Identifier: 05029867006739
• UDI-Public: (01)05029867006739
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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: 05/28/2025
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 053216696
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown