MAUDE Adverse Event Report: RAYNER INTRAOCULAR LENSES LIMITED C-FLEX

Model Number	570C
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
(b)(4).The healthcare facility reports that the predicted patient outcome was -0.32 and the patient's post-operative refraction is -5.50.No further information is available to rayner at this time.Rayner is liasing with the healthcare facility to obtain additional information to facilitate further investigation of this event.No device related cause for the deviation in target refraction has been identified.Our review of production records for the c-flex 570c iol batch 059137394 showed that all manufacturing and quality checks were conducted with successful results.All lenses 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 c-flex 570c iol (may 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 c-flex 570c iol batch 059137394.The rayner risk analysis identifies the following as possible causes of "sub-optimal visual outcome"; incorrect product selection, aniseikonia combined with unsuitable lens power selection and wrong lens power caused by incorrect biometry readings/calculations (e.G.Previous lasik procedure).
Event or Problem Description
On 5th september 2019, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred following implantation of a c-flex 570c iol.The event description provided states that the patient's predicted refractive outcome was -0.32 and post-operatively the patient refractive outcome is -5.50.

• Brand Name: C-FLEX
• Common Device Name: C-FLEX
• 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: 9075929
• Report Number: 3012304651-2019-00016
• Device Sequence Number: 16763477
• Product Code: HQL
• UDI-Device Identifier: 05029867802799
• UDI-Public: (01)05029867802799
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P060011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 570C
• Device Catalogue Number: 570C
• Device Lot Number: 059137394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1