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

Model Number 623T

Device Problems Split (2537); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

The reference (b)(4) has been allocated to this case by rayner.The healthcare facility reports that a t-flex aspheric 623t iol split during implantation necessitating explantation of the lens.In order to aid explantation of the lens, the incision was enlarged (see fda mdr 9611165-2016-00005).A back-up t-flex aspheric 623t iol was implanted; however, this lens also split and had to be explanted.A third lens was prepared and some difficulty was experienced in loading the lens.The healthcare facility has confirmed that after the initial difficulty experienced in loading the lens that the third lens was implanted successfully.As a result of the healthcare professional enlarging the incision, the patient required sutures.The event description provided by the healthcare facility states that some resistance was noted on injection.The 'injector loading' section of all rayner ifus contains the following statements "any resistance could indicate a trapped lens" and "anticipate an initial slight resistance.Excessive resistance could indicate a trapped lens.If excessive resistance is felt, fully retract the plunger and then advance until in contact with the lens again.If the lens causes a blockage in the injector system, discard the injector".Rayner has contacted the healthcare facility in order to determine if the product could be returned for inspection.Our review of production records for the t-flex aspheric 623t iol batch 124e65269 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 t-flex aspheric 623t iol (december 2014) was carried out in order to determine if any trends existed.This review concluded that one similar incident (event subject to fda mdr 9611165-2016-00005 and originating from same surgery/healthcare facility as subject to fda mdr 9611165-2016-00006) has been received against the t-flex aspheric 623t iol batch 124e65269.Device not returned to manufacturer.

Event Description

On (b)(4) 2016, rayner intraocular lenses limited received notification of an event that occurred at a (b)(6) healthcare facility during use of a t-flex aspheric 623t iol.The event description provided to rayner states "loading of the lens is manual and was carefully observed.Some resistance was noted.The lens split on two occasions and had to be explanted".

• Brand Name: T-FLEX ASPHERIC
• Type of Device: T-FLEX ASPHERIC
• Manufacturer (Section D): RAYNER INTRAOCULAR LENSES LIMITED; 1-2 sackville trading estate; sackville road; hove, east sussex BN3 7 AN; UK BN3 7AN
• Manufacturer (Section G): RAYNER INTRAOCULAR LENSES LIMITED; 1-2 sackville trading estate; sackville road; hove, east sussex BN3 7 AN; UK BN3 7AN
• Manufacturer Contact: jodie neal ; 1-2 sackville trading estate; sackville road; hove, east sussex BN3 7-AN ; UK BN3 7AN ; 1273205401
• MDR Report Key: 5436197
• MDR Text Key: 38228305
• Report Number: 9611165-2016-00006
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/26/2019
• Device Model Number: 623T
• Device Catalogue Number: 623T
• Device Lot Number: 124E65269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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