MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-30 for NOT AVAILABLE manufactured by Rayner Intraocular Lenses Limited.
[185512366]
The reference (b)(4) has been allocated to this case by rayner. The patient underwent iol implantation on (b)(6) 2015. The development of calcification is reported to have been observed for the first time on (b)(6) 2020. There is currently very limited information available to rayner. Rayner has contacted its distributor in indonesia to obtain additional information to facilitate further investigation of this event (e. G. Product information, patient medical history - prior ocular surgery, any procedures post cataract surgery). The calcification of iols has been categorised in published literature into two types; primary and secondary (plus a third for those incorrectly determined cases). Primary calcification is inherent. It is due to particular manufacturing processes or packaging interactions. An examination of the literature shows that some manufacturers have had known cases of primary calcification due to an interaction with silicone in the packaging - and more recently, due to phosphate remnants (originating from a detergent) found in the manufacturing process. Rayner has made no material processing or packaging changes that may have negatively affected our iols; we have never had a confirmed case of primary calcification relating to a rayner iol. Secondary calcification affects many manufacturers and is a phenomenon that is not fully understood; it is known that it stems from changes in the eye's environment due to patient comorbidity, secondary surgeries and potentially other, poorly understood interaction. The following have been identified as possible causes of opacification in published literature; off label use of intracameral alteplase (actilyse) (rtpa), multifactorial, high phosphate content ophthalmic viscoelastic devices , repeated exposure to intracameral air, raised intraocular pressure, excessive post-operative inflammation, complicated, traumatised eyes, as a result of direct contact between the iol surface and the exogenous gas or substance, a metabolic change in the anterior chamber due to the presence of exogenous gas/substance in the eye or an exacerbated inflammatory reaction after multiple surgical procedures, trauma or repeat surgery involved in re-bubbling potentially disrupting the blood aqueous barrier, increasing concentration of calcium ions.
Patient Sequence No: 1, Text Type: N, H10
[185512367]
On (b)(6) 2020, rayner intraocular lenses limited received notification from its distributor in indonesia of an event that occurred following implantation of an unspecified rayner iol. The event description provided states that calcification of the iol has been observed over four years post implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012304651-2020-00012 |
| MDR Report Key | 9896485 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS JODIE NEAL |
| Manufacturer Street | THE RIDLEY INNOVATION CENTRE 10 DOMINION WAY |
| Manufacturer City | WORTHING, WEST SUSSEX BN148AQ |
| Manufacturer Country | UK |
| Manufacturer Postal | BN148AQ |
| Manufacturer G1 | RAYNER INTRAOCULAR LENSES LIMITED |
| Manufacturer Street | 1-2 SACKVILLE TRADING ESTATE SACKVILLE ROAD |
| Manufacturer City | HOVE, EAST SUSSEX BN3 7AN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BN3 7AN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOT AVAILABLE |
| Generic Name | NOT AVAILABLE |
| Product Code | HQL |
| Date Received | 2020-03-30 |
| Model Number | NOT AVAILABLE |
| Catalog Number | NOT AVAILABLE |
| Lot Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAYNER INTRAOCULAR LENSES LIMITED |
| Manufacturer Address | 1-2 SACKVILLE TRADING ESTATE SACKVILLE ROAD HOVE, EAST SUSSEX BN3 7AN UK BN3 7AN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |