MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED 600C STAND ALONE

Model Number	600C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd june 2022, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred during implantation of a 600c iol.The event description provided states that the when the iol was injected into the eye it came out "slightly flipped" and as a result of correcting the lens orientation once the lens was in the eye the capsule tore.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the lens flipped during injection and that as a result of correcting the lens orientation inside the eye the capsule tore.The additional information received from the healthcare facility identifies that the lens was loaded into the injector by eye and that resistance was experienced during injection.The "directions for use" section of the ifu step 11 states ".If excessive resistance is felt this could indicate a blockage; stop and discard the injector and lens.In the case of iol rotation during ejection from the nozzle, gently rotate the injector in the opposite direction to counteract any movement." no product was available for return to rayner, the device had been discarded by the healthcare facility.A review of existing vigilance data confirms this is an isolated event.No other incidents, of any type, have been received against the 600c iol batch 1218359468.

• Brand Name: 600C STAND ALONE
• Common Device Name: 600C STAND ALONE
• 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: 14840394
• Report Number: 3012304651-2022-00038
• Device Sequence Number: 2367048
• Product Code: HQL
• UDI-Device Identifier: 05029867800238
• UDI-Public: (01)05029867800238
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2022

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
• Device Model Number: 600C
• Device Catalogue Number: 600C
• Device Lot Number: 012183594
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown