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

Model Number 610-0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Visual Impairment (2138)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

The explanted corneal inlay has not been returned to the manufacturer at this time.The site is being contacted to determine whether it is still available for analysis.The device history record review of the manufacturing lot was performed and there were no discrepancies or unusual findings related to the reported issue.Dry eye, epithelial defect, vision loss, and infection are listed in the device labeling as known potential risks.(b)(4).

Event Description

The patient underwent uneventful implantation of the raindrop corneal inlay in the right eye on (b)(6) 2017.On (b)(6) 2017, the patient presented with a corneal ulcer/possible infection and the patient's best corrected distance visual acuity had decreased from 20/20 (preoperatively) to 20/70.The size of the ulcer was approximately 5 x 5 mm, located at the 6-8 o'clock position.The eye was cultured at this visit and the culture report revealed a few gram negative rods, possible pseudomonas.It was also noted that the patient had punctal occlusion of lower and upper lids.A second culture report was unchanged and a 3rd culture showed very few possible staph species.A 4th culture report showed a few staph epi and a 5th culture was positive for staph epi and p.Acnes.On (b)(6) 2017, the patient's bcdva decreased to 20/100 and the inlay was explanted.During the procedure to lift the flap/remove the inlay and remove the epithelium sheets with a prk spatula, there was a small area of flap damage (5 x 5 mm) at the 7-9 o'clock position.The patient was treated with amniotic membrane transplantation and a bandage contact lens was placed.Medications prescribed and/or administered included: tobramycin, vancomycin, bacitracin, lotemax, gatifloxacin, sochlor, maxitrol, prolensa, and durezol.The surgeon suspects the patient's evaporative dry eye (despite treatment) was a contributing factor.The patient's prognosis is guarded with amniograft/bandage contact lens in place to heal the persistent epithelial defect.At last examination on (b)(6) 2017, the patient's bcdva was hand motion at 3 feet, but the amniotic membrane was still on the cornea.Additional follow-up will be requested.

Manufacturer Narrative

(b)(4).

Event Description

The following new information was provided to rvo.At last examination on (b)(6) 2017, the patient's best corrected distance visual acuity (bcdva) improved to 20/50.

Manufacturer Narrative

(b)(4).

Event Description

At last examination on (b)(6) 2017, the patient reported experiencing bothersome glare symptoms however her bcdva improved to 20/40 with mr +0.75 - 1.50 x 089 add +2.50.Examination revealed that the corneal opacity decreased in size to 3x3 mm at the 8:00 position and the flap edge melt was approximately 2 mm at the 7:00 to 9:00 position.All other ocular findings were within normal limits.Lotemax and gatifloxacin were discontinued and the patient was instructed to continue using bacitracin ointment at bedtime.The patient will be seen again in 2 months.

• 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: 6845575
• MDR Text Key: 85003002
• Report Number: 3005956347-2017-00098
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 108500394006013
• UDI-Public: (01)108500394006013
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/08/2019
• Device Model Number: 610-0001
• Device Lot Number: 003027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 11/06/2017; 12/12/2017
• Supplement Dates FDA Received: 12/06/2017; 01/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2016
• 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; Disability
• Patient Age: 52 YR