MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE ASPHERIC

Model Number	RAO600C
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that post-operatively, the lens decentered inferiorly.The risk analysis identifies the following as possible causes of "decentration or dislocation"; lens instability due to microphthalmia, use of incompatible surgical accessories, causing damage to lens, exposure to excessive heat (>140°c) and long term instability of eye anatomy.Rayner is following up with the healthcare facility to obtain additional information to facilitate further investigation of the event.Our review of production records for the rayone aspheric rao600c batch 0391134156 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.
Event or Problem Description
On (b)(6) 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 post-operatively the "lens decentered inferiorly".
Additional Manufacturer Narrative
The reference (b)(4) has been allocated to this case by rayner.The event description provided states that post-operatively, the lens decentered inferiorly.The patient medical history received states that the patient has glaucoma.The risk analysis identifies the following as possible causes of "decentration or dislocation"; lens instability due to microphthalmia, use of incompatible surgical accessories, causing damage to lens, exposure to excessive heat (>140°c) and long term instability of eye anatomy.In follow-up with rayner the healthcare facility stated that lens decentration had no impact to the patient visual acuity.On an unknown date post-operatively, the rayone aspheric rao600c was explanted and exchanged for "ma50bm16.5 sulcus".Our review of production records for the rayone aspheric rao600c batch 039134156 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 (march 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 rayone aspheric rao600c batch there is no evidence of a device-related cause of post-operative decentration.
Event or Problem Description
On (b)(6) 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 post-operatively the "lens decentered inferiorly".

• Brand Name: RAYONE ASPHERIC
• Common Device Name: RAYONE ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; the ridley innovation centre; 10 dominion way; worthing, BN14 8AQ; UK BN14 8AQ
• MDR Report Key: 8953783
• Report Number: 3012304651-2019-00015
• Device Sequence Number: 2510418
• Product Code: HQL
• UDI-Device Identifier: 05029867692161
• UDI-Public: (01)05029867692161
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: RAO600C
• Device Catalogue Number: RAO600C
• Device Lot Number: 039134156
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR