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

Model Number 970C

Device Problem Output Problem (3005)

Patient Problem Visual Impairment (2138)

Event Type  No Answer Provided  

Manufacturer Narrative

The reference c16190 has been allocated to this case by rayner.The healthcare professional reports that the patient's refractive outcome following implantation of a c-flex aspheric 970c iol was not as expected.The healthcare facility has stated that the patient had a refractive surprise of almost 7.0d.The patient has no significant ocular history including no previous refractive surgery, trauma or ocular surface pathology.The c-flex aspheric 970c iol was explanted and exchanged on (b)(6) 2016.The healthcare professional reports that an intraocular retinoscopy was performed during the iol exchange procedure and in correspondence with rayner stated "the patient was a -7.00 spherical streak before surgery.Her +15.00d lens was explanted and replaced with a +15.00d lens of a different lot number and was then roughly -0.5 sph by retinoscopy".The explanted c-flex aspheric 970c iol was received by rayner for evaluation on 10th january 2017.Evaluation is currently in progress, the results of the device examination and testing performed will be provided in a follow-up report.Our review of production records for the c-flex aspheric 970c iol batch (b)(4) 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 aspheric 970c iol (april 2016) in order to determine if any trends existed.This review concluded that no other incidents, of any type, have been received against the c-flex aspheric 970c iol batch (b)(4).

Event Description

On (b)(6) 2016, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred following implantation of a c-flex aspheric 970c iol.The event description provided states that the surgeon used the 970c in a patient and received a post-op surprise of almost 7d.

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The healthcare professional reports that the patient's refractive outcome following implantation of a c-flex aspheric 970c iol was not as expected.The healthcare facility has stated that the patient had a refractive surprise of almost 7.0d.The patient has no significant ocular history including no previous refractive surgery, trauma or ocular surface pathology.The c-flex aspheric 970c iol was explanted and exchanged on (b)(6) 2016.The healthcare professional reports that an intraocular retinoscopy was performed during the iol exchange procedure and in correspondence with rayner stated "the patient was a -7.00 spherical streak before surgery.Her +15.00d lens was explanted and replaced with a +15.00d lens of a different lot number and was then roughly -0.5 sph by retinoscopy".Testing performed on the returned c-flex aspheric 970c iol identified the power of the lens to be between +24.0d and +24.5d.The whole batch has either been implanted without reported incident (to date) or optically tested and found to be correct.The risk of identifying a further refractive error in the batch is remote.

Event Description

On 20th december 2016, rayner intraocular lenses limited received notification from a us healthcare facility of an event that occurred following implantation of a c-flex aspheric 970c iol.The event description provided states that the patient's visual outcome post-operatively was overcorrected by almost 7.0d.

• Brand Name: C-FLEX ASPHERIC
• Type of Device: C-FLEX ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; 1-2 sackville trading estate; sackville road; hove, east sussex BN37A N; UK BN37AN
• Manufacturer (Section G): RAYNER INTRAOCULAR LENSES LIMITED; 1-2 sackville trading estate; sackville road; hove, east sussex BN37A N; UK BN37AN
• Manufacturer Contact: jodie neal ; 1-2 sackville trading estate; sackville road; hove, east sussex BN37A-N ; UK BN37AN ; 1273205401
• MDR Report Key: 6245332
• MDR Text Key: 64610943
• Report Number: 9611165-2017-00001
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/12/2021
• Device Model Number: 970C
• Device Catalogue Number: 970C
• Device Lot Number: 046E83145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention