• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 1DM
Device Problem No Apparent Adverse Event (3189)
Patient Problems Inflammation (1932); Irritation (1941); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Discomfort (2330)
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative
Eval: no testing methods performed. No results available since no evaluation performed. Unable to confirm complaint. Device not returned.
Event Description
On (b)(4) 2017 a johnson and johnson sales representative in (b)(4) reported that an eye care provider (ecp) advised a patient (pt) came to the eye clinic and was diagnosed with right eye cornea ¿covered with plenty of staining¿ while using the 1-day acuvue moist brand contact lens. It was reported the ¿cornea seemed to be opacified due to plenty of staining. ¿ the pt was prescribed flumetholon ophthalmic suspension, hyalurotate na ophthalmic solution and pain relief product (eye drops or oral medicine unknown). The pt was instructed to return to the clinic the same evening. On (b)(6) 2017, the pt went back to the clinic after six hours. It was reported as compared to the earlier visit, the staining seemed slightly improved. No information was provided on a return to the clinic or discontinuation of lens wear. The sales representative reported he/she would return a call after collecting additional medical information and ecp contact information. On (b)(4) 2017 the sales representative called and provided additional information: the pt had right eye pain when inserting the suspect lens. On (b)(6) 2017 the pt went to the ecp due to persistent pain after removing the suspect lens. The pt was prescribed an oral medication for pain relief, the name of the medication and dosage were not provided. On (b)(6) 2017 the pt went back to the eye clinic for a follow-up visit and the symptoms were improving. The pt was instructed to return to the clinic in one week. On (b)(4) 2017 a call was received from the sales representative and additional information was provided: the clinic contacted the sales representative to report the pt returned to the clinic (b)(6) 2017 and it was noted that the pt had slight inflammation in the right eye. The pt requested a call on (b)(6) 2017. On (b)(4) 2017 a call was placed to the pt and additional information was provided: the pt reported he/she did not see any visible defect on the suspect lens before inserting the lens in the right eye. On (b)(6) 2017 the pt reported right eye acute pain or stinging sensation with redness in the right eye. The pt removed the right eye suspect lens and experienced blurry vision. The pt went to an ecp at 9:00 am and was advised the right eye vision was ¿not good enough¿. The pt reported the ecp advised the ¿cornea right eye was clouded as if it were inflammation caused by a chemical agent¿. The pt was prescribed flumetholon ophthalmic suspension and hyalurotate na ophthalmic solution. The ecp instructed the pt to discontinue cl wear for od. The pt reported after returning home, the pt developed acute pain and lid swelling od in the afternoon. In the afternoon, the pt returned to the clinic. The pt was prescribed pain-relief pills. The pt reported right eye pain on (b)(6) 2017. On (b)(6) 2017 the pt reported a f/u visit to the ecp who advised the pt that the right eye vision was better than four days ago. The staining was reported as recovering. Pt was prescribed hyalurotate na ophthalmic solution. On (b)(6) 2017 the pain in the right eye resolved, but the pt continued to experience discomfort; cloudiness of vision resolved. On (b)(6) 2017 the pt went for an additional f/u visit and was advised the staining was remaining on the central cornea right eye, which made astigmatism worse; except for the central staining, other staining was on the way to recovery; pt was instructed to discontinue lens wear and return to the clinic in a week. The pt was prescribed hyalurotate na ophthalmic solution. On (b)(6) 2017 the pt reported right eye discomfort. On (b)(4) 2017 a medical interview was conducted with the pts treating ecp and additional information was provided: diagnosis: corneal epithelium disorder od; focal site: whole extent of the cornea, currently only the central part of the cornea; on the morning of (b)(6) 2017 the pt came to the clinic and the entire cornea was stained with fluorescein, central part was particularly stained; slit lamp examination: the cornea was not transparent but was steamy, even though the iris was visible; corneal opacity as if it were steaming was observed and the pt complained about difficulty seeing; the pt did not report on pain od. In the evening of (b)(6) 2017 the pt returned for f/u with complaints of acute pain, eyelid swelling and tearing od; pt also reported difficulty seeing; part of the cornea, central and part of periphery, already returned to transparent, which seemed to be effect of eye drops; the pt went home wearing eye patch on od. On (b)(6) 2017 fu visit: right eye pain got better; the cornea was nearly clean on (b)(6) 2017 fu visit: the cornea almost restored to its former state; however, based on vital stain, cornel epithelium disorder in central part was slightly persisting; the ecp reported that the staining caused corneal astigmatism and that made vision acuity poor; however, the ecp reported the visual should return to normal; infectiveness: denied culture: not conducted; va affect: admitted; corrected va: (b)(6) 2017: 0. 4 (20/50); (b)(6) 2017: 0. 7 (20/100) ; and (b)(6) 2017: 0. 7(20/100). Prescription: flumetholon ophthalmic suspension 0. 1 qid, discontinued on (b)(6) 2017. Hyalonsan ophthalmic solution 0. 1% qid still ongoing; voltaren tid oral and mucosta tablets for 2 days were prescribed on (b)(6) 2017; instruction to discontinue cl wear: ongoing until the next follow-up; instruction to return to the clinic: in a week, around (b)(6) 2017. The suspect lens was discarded. Seriousness: not serious; the progress up to the present, it is quite unlikely that the pt suffers after effect like permanent va decrease; outcome: improvement on (b)(6) 2017, the pt contacted our customer service and requested us to contact the pt this afternoon as the pt is waiting for our contact. On (b)(4) 2017 a call was placed to the pt and additional information was provided: the pt returned for a fu visit with the ecp on (b)(6) 2017 and reported the staining was ¿practically resolved¿ although astigmatism was slightly remaining. The treatment was discontinued. On (b)(4) 2017 a medical interview was conducted with the pts treating ecp and additional information was provided: on (b)(6) 2017 fu visit: recovery confirmed; central staining almost disappeared; corrected va return to 1. 0 (20/20), the va that used to be; the pt may still be applying hyalonsan ophthalmic solution prn as three bottles were prescribed; pt was not instructed to discontinue cl wear, but advised that wearing spectacles frequently was preferable; no instruction to rtc; pt comes to the clinic regularly to have eye test. No additional medical information was provided. A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing. All parameters tested were within specification. All sterilization requirements were successfully completed. Lot 2743850111 was produced under normal conditions. If additional information is received it will be reported within 30 days of receipt. Serious reportable event trends are reviewed quarterly in franchise management review meetings.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
one technological park plassey
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
MDR Report Key6996403
MDR Text Key90944295
Report Number9617710-2017-05050
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2022
Device Catalogue Number1DM
Device Lot Number2743850111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/02/2017 Patient Sequence Number: 1