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 Capsular Contracture (1761)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.Cataract surgery was performed on (b)(6) 2017 and the 600c iol was implanted in the patient's os eye.On an unknown date post iol implantation, capsular phimosis was observed.No information, other than the initial event description, is available to rayner at this time.Rayner is liaising with its distributor in france to obtain additional information to facilitate further investigation of this report.No conclusions can be drawn at this time regarding causality.Our review of production records for the rayone aspheric rao600c batch 077108767 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 ((b)(6) 2017) was carried out in order 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 (b)(4).Note: capsular phimosis can occur following cataract surgery.All rayner iols are made of the same hydrophillic acrylic material.

Event Description

On (b)(6) 2018, rayner intraocular lenses limited received notification from its french distributor of an event that occurred following implantation of a rayone aspheric rao600c.The event description provided states that the patient has capsular phimosis post cataract surgery.

Manufacturer Narrative

The reference c18016 has been allocated to this case by rayner.Cataract surgery was performed on 14th december 2017 in the os eye.Misting of the iol had been detected on 21st december 2017 and capsular phimosis was observed on 17th january 2018.The healthcare facility confirmed that there had been no impact to the patient's visual acuity as a result of capsular phimosis; however, has reported that they performed an iol exchange as the lens was not centered.No further details on the iol exchange procedure have been made available to rayner.The patient medical history received states that the patient has diabetes, glaucoma and astigmatism.Rayner ifus contraindicate "active ocular diseases (e.G.Chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)".Accs has been associated with multiple entities.Most common is a small diameter capsulorhexis.Zonular weakness, chronic intraocular inflammation, uveitis, pesudoexfoliation syndrome, retinitis pigmentosa, advanced age, diabets mellitus, behcet's syndrome, myotonic muscular dystrophy and high myopia are also known risk factors.Our review of production records for the rayone aspheric rao600c batch 077108767 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 (july 2017) was carried out to determine if any trends existed.This review concludes that no other incidents, of any type, have been received against the rayone aspheric rao600c batch 077108767.Note: capsular phimosis can occur following cataract surgery.All rayner iols are made of the same hydrophilic acrylic material.

Event Description

On 8th february 2018, rayner intraocular lenses limited received notification from its distributor in france of an event that occurred following implantation of a rayone aspheric rao600c.The healthcare facility reports that capsular phimosis was observed on 17th january 2018; however, also states that misting of the iol had previously been detected on 21st december 2017.

• 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
• MDR Report Key: 7284987
• MDR Text Key: 100772741
• Report Number: 9611165-2018-00003
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/20/2019
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 077108767
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1