MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

Model Number	RAO200E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The verbatim report states "emv iol shot out of injector breaking posterior capsule".The rao200e iol was cut and explanted from the eye and exchanged for a 3-piece lens.An anterior vitrectomy was also performed.The rao200e iol was discarded following explantation; however, the associated injector has been retained.Rayner has requested the return of the injector for inspection/testing.Within the rayone preloaded injector use risk analysis we identify advancing the plunger too quickly and a forcing a jammed plunger during iol insertion as possible causes of "explosive expulsion of lens".The description of the lens shooting out of the injector indicates that the lens might have become trapped during injection and that continued depression of the plunger has resulted in fast expulsion of the iol from the injector.The rayone ifu "use of rayone" section "fig 7" states ".If excessive resistance is felt this could indicate a blockage; stop and discard the injector and lens".Our review of production records for the rayone emv rao200e batch 031164679 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 confirms this is an isolated report.No other reports, of any nature, have been received against the rayone emv rao200e batch 031164679.Rayner is following up with the reporting healthcare facility to obtain additional information to facilitate further investigation of the event.
Event or Problem Description
On (b)(6) 2021, rayner intraocular lenses limited received notification from its us affiliate company of an event that occurred during use of a rayone emv rao200e.The event description received states "emv iol shot out of injector and broke posterior capsule".

• Brand Name: RAYONE EMV
• Common Device Name: RAYONE EMV
• 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: 11870034
• Report Number: 3012304651-2021-00022
• Device Sequence Number: 16944553
• Product Code: HQL
• UDI-Device Identifier: 05029867006753
• UDI-Public: (01)05029867006753
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: 03/03/2023
• Device Model Number: RAO200E
• Device Catalogue Number: RAO200E
• Device Lot Number: 031164679
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2021
• Initial Report FDA Received Date: 05/24/2021
• 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: 59 YR