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 Problems Inflammation (1932); Iritis (1940)

Event Type  malfunction  

Event Description

On 2nd december 2021, 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 "8 cases of plastic iritis needing yag to membrane forming over anterior face of capsule".

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states "8 cases of plastic iritis needing yag to membrane forming over anterior face of capsule".In follow-up communication with rayner, the healthcare professional revised the event description to "with iritis it is more of a massive aco that forms daily regardless of yag daily.It is dense white film over the anterior face of lens.Not posterior.No cell and flare.But massive aco that grows daily".The revised event description received suggests that the patients are experiencing anterior capsular contraction syndrome (accs) as opposed to iritis as originally reported.Anterior capsule fibrosis and phimosis, commonly described as accs is described in published literature as the centripetal constriction and fibrosis of the capsulorhexis following cataract removal.Accs has been associated with multiple entities.Most common is a small diameter capsulorhexis.Zonular weakness, chronic intraocular inflammation, uveitis, pseudoexfoliation syndrome, zonular laxity, retinitis pigmentosa, advanced age, diabetes mellitus, behcet's syndrome, myotonic muscular dystrophy, and high myopia, are known risk factors.Accs is rarely reported to rayner and our incident rate for the period january 2016 - november 2021 is (b)(4).No cases of accs reported to rayner have been found to be causally related to the iol.

• 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: 12982991
• MDR Text Key: 282105586
• Report Number: 3012304651-2021-00072
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• 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: NOT AVAILABLE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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