MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The healthcare facility reports that the patient was unable to read post-operatively and as a result an iol exchange was performed.To rayner's knowledge, the iol was discarded following explant.Rayner is following up with the healthcare facility to obtain additional information to facilitate further investigation of this event.Our review of production records for the rayone aspheric rao600c batch 128129389 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 (december 2018) was carried out 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 128129389.
Event or Problem Description
On 12th august 2019, 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 that an intraocular lens exchange was performed as the patient was unable to read.
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The patient underwent implantation of a rayone aspheric rao600c +15.0 d iol in the od eye on (b)(6) 2019.The intended post-op outcome was 20/20 and the post-op biometry was 20/20.An intraocular lens exchange was performed on 7th august 2019 as the patient was unable to read.The patient received a rayone aspheric +13.0 d.The healthcare facility has confirmed that following lens exchange the patient's vision has been corrected.To rayner's knowledge, the iol was discarded following explant.Rayner's optics team has reviewed the available information and re-calculated the required lens power based on the biometry data provided.Their power estimate for emmetropia was +14.0 d.Our review of production records for the rayone aspheric rao600c batch 128129389 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 (december 2018) was carried out 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 128129389.No device-related cause for the event has been established.
Event or Problem Description
On 12th august 2019, 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 that an intraocular lens exchange was performed as the patient was unable to read.

• Brand Name: RAYONE ASPHERIC
• Common Device Name: 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: 8896697
• Report Number: 3012304651-2019-00013
• Device Sequence Number: 371902
• Product Code: HQL
• UDI-Device Identifier: 05029867692147
• UDI-Public: (01)05029867692147
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2020
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 128129389
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR