MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided to rayner states "after the iol was halfway out of the injector and in the eye, the iol quickly came out the rest of the way.The lens shot forward very quickly and caused the zonules to be stretched.Vitreous came up and a vitrectomy had to be performed.A capsular tension ring was inserted and the iol was left in the eye".The rayner risk analysis identifies the following as possible causes of "explosive expulsion of lens"; plunger advanced too quickly and forcing jammed plunger during iol insertion.There is currently insufficient information available to determine the cause of the event.Rayner is following up with the healthcare facility to obtain additional information to facilitate further investigation of the event.The iol remains implanted; however, the associated injector has been retained and is expected to be returned to rayner.The findings of our device inspection will be provided in a follow-up report.Our review of production records for the rayone aspheric rao600c batch 128129488 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 (december 2018) 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 128129488.
Event or Problem Description
On (b)(6) 2019, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred during use of a rayone aspheric rao600c.The event description provided states "after the iol was halfway out of the injector and in the eye, the iol quickly came out the rest of the way.The lens shot forward very quickly and caused the zonules to be stretched".

• Brand Name: RAYONE ASPHERIC
• Common Device Name: RAYONE ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, BN14 8AQ; UK BN14 8AQ
• MDR Report Key: 9437116
• Report Number: 3012304651-2019-00025
• Device Sequence Number: 2306019
• Product Code: HQL
• UDI-Device Identifier: 05029867692215
• UDI-Public: (01)05029867692215
• 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): 12/09/2019

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: 12/19/2020
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 128129488
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/09/2019
• 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: 73 YR