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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV

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RAYNER INTRAOCULAR LENSES LIMITED RAYONE EMV Back to Search Results
Model Number RAO200E
Device Problem 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 visual outcome of the patient post-operatively was not as expected.The patient underwent an additional surgical procedure to have the rayone emv rao200e explanted and exchanged."deviation from target refraction" and "iol replacement or extraction" are listed in the "adverse events" section of the rayone ifu.There are many factors which may influence the post-operative outcome of the patient including but not limited to; incomplete removal of ovd following iol implantation (capsular block/capsular bag distension syndrome), dry eye during biometry measurement, incorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power caused by incorrect biometry readings/calculations (e.G., previous lasik procedure), incorrect power selection (not using optimised a-constants may be a contributory factor in this scenario - surgeons must always expect to personalise their own constants based on initial patient outcomes, with further personalisation as the number of eyes increases.), posterior synechiae, irregular capsular bag contraction, patient medical history (e.G., glaucoma, pseudoexfoliation syndrome), lens decentration or dislocation, incorrect or unstable fixation within the capsular bag, post-operative rotation of the lens, lens does not fit anatomy of the eye (e.G., too large or too small), capsulorhexis diameter too large and induced surgical astigmatism.There is insufficient information to establish the cause of the deviation in target refraction in this case.Rayner is following up via its in-country representatives to obtain additional information.The return of the explanted iol is also being sought for evaluation.
 
Event Description
On 1st april 2024, rayner received notification from its us healthcare facility of an event that occurred following implantation of a rayone emv rao200e.The event description provided states that the healthcare professional explanted the rayone emv rao200e post-operatively as the patient's visual outcome was not as expected.
 
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Brand Name
RAYONE EMV
Type of Device
RAYONE EMV
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 Key19123439
MDR Text Key341260692
Report Number3012304651-2024-00091
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 04/17/2024
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 Model NumberRAO200E
Device Catalogue NumberRAO200E
Device Lot NumberNOT AVAILABLE
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/17/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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