MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE SPHERIC

Model Number	RAO100C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
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 capsular bag collapsed during iol implantation.The iol was explanted and exchanged during the original surgery session.A suture was placed to secure iol fixation."iol replacement or extraction" is listed in the "adverse events" section of the rayone ifu.Our review of production records for the rayone spheric rao100c batch 095280365 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 095280365.The information received identifies that the patient had zonular weakness.The rayner ifu "warnings" section states "a risk/benefit ratio must be assessed before confirming a patient as a candidate for the rayner 600c or 100c iool implantation, if they are suffering from any of the following conditions:.Zonular dehiscence.A distorted eye due to previous trauma or developmental defect in which appropriate support of the iol is not possible".Capsular bag collapse is attributable to zonular weakness.
Event or Problem Description
On 27th may 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 the patient had zonular weakness and the capsular bag collapsed during iol implantation.

• 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 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: 25392490
• Report Number: 3012304651-2026-00169
• Device Sequence Number: 10719060
• Product Code: HQL
• UDI-Device Identifier: 05029867689567
• UDI-Public: 05029867689567
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RAO100C
• Device Catalogue Number: RAO100C
• Device Lot Number: 095280365
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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