MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED SUPERFLEX ASPHERIC

Model Number 920H

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient's refraction following implantation of a superflex aspheric 920h iol was not as expected.The target refraction was -3.0 d and the patient's post-operative refraction was -17.0 d.The superflex aspheric 920h iol was explanted on (b)(6) 2020.The lens has been retained and is currently in transit to rayner for analysis.Rayner is following up with its distributor in (b)(6) to obtain additional information to facilitate further investigation of the event.A review of existing vigilance data from the month of manufacture of the superflex aspheric 920h iol ((b)(6) 2019) was carried out to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the superflex aspheric 920h iol batch 059135611.

Event Description

On (b)(6) 2020, rayner intraocular lenses limited received notification from its (b)(6) distributor of an event that occurred following implantation of a superflex aspheric 920h iol.The event description provided states that the target refractive outcome was -3.0 d and that post iol implantation the patient's refraction was -17.0 d.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient's refraction following implantation of a superflex aspheric 920h iol was not as expected.The target refraction was -3.0 d and the patient's post-operative refraction was -17.0 d.The superflex aspheric 920h iol was explanted on (b)(6) 2020 and was returned to rayner for power testing.The returned lens was found to be in the region of +16.0 d.Testing of the returned lens confirms the power of the lens is not as labelled (superflex aspheric 920h +1.0 d).As the lens was cut to facilitate explantation the accuracy of the measurement has been slightly constrained; however, rayner's optics team confirm the power measurement to be correct to within ±1.0 d.Rayner's production process includes a 100% lens optical power check and a 100% check of optical quality via mtf (modulation transfer function); both checks are carried out in accordance with the requirements of iso 11979 (ophthalmic implants - intraocular lenses).After power and mtf determination, lenses are passed into our clean room, where they are individually checked for cosmetic flaws and sealed into primary packaging, labelled, and then transferred to the autoclave for sterilisation.Our root cause investigation has concluded that a single lens with a power of +16.5 d from the batch processed immediately before the superflex aspheric 920h iol batch 059135611 was inadvertently transferred into the superflex aspheric 920h +1.0 d batch 059135611 which directly followed it through the production department.A corrective and preventive action (capa) has been raised by rayner in response to this case.

Event Description

On (b)(6) 2020, rayner intraocular lenses limited received notification from its chinese distributor of an event that occurred following implantation of a superflex aspheric 920h iol.The event description provided states that the target refractive outcome was -3.0 d and that post iol implantation the patient's refraction was -17.0 d.

• Brand Name: SUPERFLEX ASPHERIC
• Type of Device: SUPERFLEX 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: 10078549
• MDR Text Key: 191679269
• Report Number: 3012304651-2020-00013
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05029867250224
• UDI-Public: (01)05029867250224
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

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 Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 920H
• Device Catalogue Number: 920H
• Device Lot Number: 059135611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR