MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number RAO600C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 11/18/2022

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(6) has been allocated to this case by rayner.The patient underwent iol implantation on (b)(6) 2022 and one day post-operatively presented with toxic anterior segment syndrome (tass).Disposable surgical instruments were used and surgery was performed without complication.The patient has been prescribed yellox x2 daily, vancomycin fortum infusions, has undergone pars plana vitrectomy and vitroeus tap (no germ detectable).The healthcre facility has confirmed that the patient's symptoms have resolved following treatment.The aetiology of tass may be multi-factorial with numerous potential causes including but not limited to; bacterial endotoxins or particulate contamination of balanced salt solutions, intraocular irrigating solutions with abnormal ph, osmolarity or ionic composition, denatured ophthalmic viscosurgical devices (ovd), intraocular medications (antibiotics in the irrigation solutions or intracameral antibiotics), topical ointments, inadequate sterilization of surgical instruments and tubing, inadequate flushing of instruments between cases resulting in build-up of ophthalmic viscosurgical devices (ovd), preservative and metallic precipitate.Every batch of iols manufactured by rayner are tested for endotoxin and bioburden.Rayner's endotoxin acceptable tolerances are derived from bs en iso 11979-08 (2017) ophthalmic implants - intraocular lenses part 8 fundamental requirements.We have set our own limits for bioburden as there is no standard that prescribes acceptable limits.Our review of endotoxin and bioburden records for the batch confirms that the product tested within acceptable tolerance of the respective limits.No rayner microbiological cause for the onset of post-operative tass was identified.The root cause of the event has not been established.

Event Description

On 29th november 2022, rayner received notification from an austrian healthcare facility of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that one day post-operatively the patient presented with toxic anterior segment syndrome (tass).

• Brand Name: RAYONE ASPHERIC
• Type of Device: RAYONE ASPHERIC
• 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: 15903983
• MDR Text Key: 307912566
• Report Number: 3012304651-2022-00114
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867691720
• UDI-Public: (01)05029867691720
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 072196359
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female