MAUDE Adverse Event Report: REVISION OPTICS RAINDROP NEAR VISION INLAY; CORNEAL INLAY

Model Number 610-0001

Device Problems Contamination (1120); Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Irritation (1941); Loss of Vision (2139); No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

The device history record for this manufacturing lot was reviewed and the device met all release criteria and there were no discrepancies or unusual findings that relate to the reported event.The explanted inlay was discarded by the facility and is not available for evaluation.Please reference the medication alert for durezol.(b)(4).

Event Description

The patient underwent implantation of the raindrop corneal inlay in the left eye on (b)(6) 2016.During surgery, durezol was instilled on the stromal bed.At the slit-lamp examination immediately following implantation (day 0), the interface was not clear and debris of unknown origin was observed.The patient was monitored and the interface debris did not progress, but did not improve.The interface debris was suspected to be residual durezol.On (b)(6) 2016, the inlay was explanted and the interface was copiously irrigated with balanced salt solution (bss) then durezol was placed on the stromal bed, followed by copious irrigation with bss and a new raindrop inlay was implanted.Additional information is being requested.

Manufacturer Narrative

(b)(4).Reference mdr# 3005956347-2017-00021 for the replacement inlay.

Event Description

On january 21, 2017, additional information was received and it was learned that excessive patient movement during the initial surgery on (b)(6) 2016 resulted in an epithelial defect.As reported in mdr# 3005956347-2017-00021, this same patient had a similar adverse event with the second raindrop inlay that was implanted on (b)(6) 2016.

• Brand Name: RAINDROP NEAR VISION INLAY
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest CA 92630 8835
• Manufacturer (Section G): REVISION OPTICS; 25651 atlantic ocean dr.,; ste. a1; lake forest CA 92630 8835
• Manufacturer Contact: pushpita singh ; 25651 atlantic ocean dr.,; ste. a1; lake forest, CA 92630-8835 ; 9497072740
• MDR Report Key: 6252053
• MDR Text Key: 64885297
• Report Number: 3005956347-2017-00007
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 10850394006013
• UDI-Public: (01)10850394006013(17)190822(10)002984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: 610-0001
• Device Lot Number: 002984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005956347-02/03/17-001
• Patient Sequence Number: 1
• Treatment: DUREZOL; FEMTOSECOND LASER FOR CREATION OF CORNEAL FLAP
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR