MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The patient underwent implantation of a rayone aspheric rao600c +28.0 d in the os eye on (b)(6) 2019.At the one day post-operative consultation, the healthcare facility identified that the patient refractive outcome was not as intended.The healthcare facility reports that the patient presented with a myopic surprise.Residual ovd in the capsular bag (capsular block) could be a potential cause of the myopic outcome, however, there is currently insufficient information available to determine the cause of the myopic outcome.Rayner is following up with the healthcare facility to obtain additional information to facilitate further investigation of the reported event.A review of existing vigilance data from the month of manufacture of the rayone aspheric rao600c (march 2019) was carried out to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the rayone aspheric rao600c; batch 039133568.
Event or Problem Description
On 8th november 2019, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that post-operatively the patient had a myopic surprise.

• Brand Name: RAYONE ASPHERIC
• Common Device Name: RAYONE ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, west sussex BN14 8AQ; UK BN14 8AQ
• MDR Report Key: 9320362
• Report Number: 3012304651-2019-00022
• Device Sequence Number: 2243387
• Product Code: HQL
• UDI-Device Identifier: 05029867692406
• UDI-Public: (01)05029867692406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PO60011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 03/10/2021
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 039133568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR