MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RayOne Spheric

Model Number	RAO100C
Medical Device Problem Codes	Material Integrity Problem (2978); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
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 immediately following implantation into the eye there were creases and the iol was scratched.The iol was explanted and exchanged during the original surgery session without further incident.There was no harm or injury to the patient."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.The device was not returned.The creases observed post implantation may be in the capsule itself.Capsule folds can occur due to the high radial force exerted on the capsular bag during iol implantation.The cause of the reported scratches cannot be determined from the limited evidence and information available.Our reveiew of production records for the rayone spheric rao100c batch 075275825 showed that all manufacturing and quality checks were conducted with successful results.A review of vigilance data confirms this is an isolated event.No other incidents, of any type, have been received against the rayone spheric rao100c batch 075275825.Without the ability to examine the device and without clear event details being provided it is not possible to establish root cause.
Event or Problem Description
On 29th april 2026, rayner received notification from a us healthcare facility of an event that occurred during use of a rayone spheric rao100c.The event description provided states that after the iol unfolded in the eye it was creased and had scratches on necessitating lens explantation and exchange.

• Brand Name: RayOne Spheric
• Common Device Name: RayOne Spheric
• 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 BN18 4AQ; UK BN18 4AQ
• Manufacturer Contact: jodie neal ; the ridley innovation centre; 10 dominion way; worthing, west sussex BN18 -4AQ ; UK BN18 4AQ
• MDR Report Key: 25092676
• Report Number: 3012304651-2026-00146
• Device Sequence Number: 21276546
• Product Code: HQL
• UDI-Device Identifier: 05029867689642
• UDI-Public: 05029867689642
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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 Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 075275825
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2025
• 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