MAUDE Adverse Event Report: ACUFOCUS, INC. KAMRA; CORNEAL INLAY

Model Number ACI 7000

Device Problem Wrinkled (2614)

Patient Problem Inflammation (1932)

Event Date 09/19/2015

Event Type  Injury  

Manufacturer Narrative

Dhr review: a review of the device history record was performed and there were no discrepancies noted that relate to the event.Production process control review: a review of the process control records regarding the sterilization of the device confirmed the sterilization cycle for this lot (batch) met the required specifications (including results of the biological indicators).The endotoxin testing for this lot via lal testing found the batch contained less than 0.2 eu/device and was acceptable for release.Additionally, acufocus takes quarterly bioburden samples to ensure the consistency of the production process and no changes have occurred to the product which have affected the efficacy of the sterilization cycle.Returned device analysis.The device was returned to acufocus, inc.On (b)(4) 2015.A visual analysis found the inlay was wrinkled, consistent with being explanted.Additionally, the inlay was stuck to a piece of tape.When acufocus attempted to remove the tape from the inlay, the inlay tore in two.As such, the inlay could not be measured therefore; a dimensional analysis could not be performed.Lot history a532-0214.A review of the complaint history for production lot (batch) a532-0214 was performed.A total of three (3) other complaints were received for this lot.However, none of the other complaints were classified as adverse events requiring vigilance reporting nor were they due to inflammation.Preliminary assessment: based on the reported information and preliminary analysis including no noted discrepancies in the dhr that relate to the event, there is no evidence to suggest the event is systemic and/or device related.Surgeon training: acufocus' surgeon training includes the plk2 (planned lasik kamra 2 step) which describes performing a standard flap creation with excimer ablation treatment (lasik) followed by pocket creation and kamra inlay implantation at a minimum of one (1) month post lasik treatment.The procedures performed in this event were performed consecutively on the same day, and therefore are not consistent with acufocus' recommendations.Labeling review: based on the reported event information, the procedure type was same day lasik and kamra implantation in secondary lamellar pocket.The united states labeling (p/n (b)(4)) for the kamra inlay includes the following precaution: "the safety and effectiveness of the kamra inlay implantation in conjunction or in sequence with lasik or other refractive procedures is not known." acufocus has not reached a conclusion into the root cause of infection/inflammation events from optilase eye clinics.However, based on information known to date, there is insufficient evidence to suggest the reported events are systemic and/or device related based on acceptable acufocus dhr/sterility review, complaint trending on affected lots and product evaluations.Acufocus has initiated a more thorough assessment of the clinic's practices in attempt to identify a root cause for the reported events and has established capa (b)(4) in the acufocus quality management system.As part of the investigation plan, acufocus visited the optilase eye clinics in the republic of ireland and northern ireland in late october to conduct a review the patient files associated with the reported events, assess the surgical practices and procedures used for kamra implantation, surgical suites/environmental controls, tools and equipment, preoperative and postoperative medication regimen and is in the process of summarizing the visit findings.The investigation is in-progress and findings will be recorded on capa (b)(4).A summary of our findings will be provided to the nca upon completion.

Event Description

On (b)(6) 2015, acufocus, inc.Was made aware that a patient had a severe inflammatory reaction and the kamra inlay was explanted 33 days postoperatively.

• Brand Name: KAMRA
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer (Section G): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: sandra selvaggi ; 32 discovery; suite 200; irvine, CA 92618 ; 9495859511
• MDR Report Key: 5203113
• MDR Text Key: 30453954
• Report Number: 3008401069-2015-00007
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2019
• Device Model Number: ACI 7000
• Device Catalogue Number: 76195
• Device Lot Number: A532-0214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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
• Patient Age: 52 YR