MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/13/2019
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 uncomplicated cataract (phaco) extraction and iol insertion on (b)(6) 2019 and that one day post-operatively the iol had completely subluxed necessitating a pars plana vitrectomy.Trauma, prior vitreoretinal surgery, pseudoexfoliation syndrome (a condition that causes instability of the capsular bag where the iol is placed), certain connective tissue disorders and inflammation in the eye (such as eye uveitis) are known risk factors for iol subluxation.The rayner risk analysis also identifies the following as possible causes of iol subluxation; lens instability due to microphthalmia, use of incompatible surgical accessories causing damage to lens, exposure to excessive heat (>140 degrees celsius) and long term instability of eye anatomy."iol dislocation and subluxation is listed in the "adverse events" section of the rayone ifu.There is currently insufficient information available to determine the cause of lens subluxation in this case.Rayner is following up with the healthcare facility to obtain additional information.Our review of production records for the rayone aspheric rao600c batch 049136086 showed that all 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 existing vigilance data from the month of manufacture of the rayone aspheric rao600c (april 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 049136086.
Event or Problem Description
On 7th december 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 one day post-operatively "iol completed subluxed" necessitating a pars plana vitrectomy.

• 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: 9449647
• Report Number: 3012304651-2019-00027
• Device Sequence Number: 2114427
• Product Code: HQL
• UDI-Device Identifier: 05029867692314
• UDI-Public: (01)05029867692314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• 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): 12/11/2019

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 Expiration Date: 04/25/2021
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 049136086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR