MAUDE Adverse Event Report: PT. CIBA VISION BATAM AIR OPTIX NIGHT & DAY AQUA; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 000000000010043868

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Chemosis (1775); Corneal Abrasion (1789); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Visual Disturbances (2140); Excessive Tear Production (2235); Eye Pain (4467)

Event Date 10/08/2023

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: the complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by the consumer, she stated that her eyelid was swollen, she could not see anything from her left eye.Consumer also complained of foreign body sensation, photophobia, scratch on the eye and tearing from her left eye for which she consulted ecp on (b)(6) 2023.The diagnosis of with corneal scarring and corneal ulcer on her left eye was provided by the ecp after conducting diagnostic tests of her eyes suspected that possible scratch on the left eye was due to sleeping with contact lenses on during night.Consumer was prescribed with antibiotic ofloxacin 0.3% ophthalmic solution, one drops four times a day for seven to ten days and follow up was scheduled following five days.The status of the consumer's eye was unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

B5:,b6:,- safety event description updated and relevant tests and lab findings information added.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by the consumer, she stated that her eyelid was swollen, she could not see anything from her left eye.Consumer also complained of foreign body sensation, photophobia, scratch on the eye and tearing from her left eye for which she consulted ecp on b)(6) 2023.The diagnosis of with corneal scarring and corneal ulcer on her left eye was provided by the ecp after conducting diagnostic tests of her eyes suspected that possible scratch on the left eye was due to sleeping with contact lenses on during night.Consumer was prescribed with antibiotic ofloxacin 0.3% ophthalmic solution, one drops four times a day for seven to ten days and follow up was scheduled following five days.The status of the consumer's eye was unknown.Additional information has been requested but not yet received.On (b)(6) 2023 medical record received from the consumer during follow up revealed the following information: consumer has undergone ophthalmic examination on (b)(6) 2023 for both eyes.A.Ophthalmic examination: od and os external: normal lid position; nasolacrimal and orbital exam, od, and os lid margin: quiet and normal was found to be normal b.Slit lamp examination od and os conjunctiva: white and quiet, anterior chamber: deep and quiet anterior chamber, iris: normal iris without rubeosis and lens: clear lenes, od corneal: clear cornea, os cornea was found with corneal scarring and corneal ulcer, a dilated exam of the optic disc was performed for both od and os.C.Ophthalmoscopic examination of optic disc: od and os optic disc: flat and normal disc, lens used: 90d a dilated fundus exam was performed for both od and os.D.Ophthalmoscopic examination of retina and vessels: od and os: vitreous: vitreous clear without hemorrhage, cells or pigment, vessels: vessels with normal contour, caliber without neovascularization, macula: macula normal contour without heme, edema, drusen or exudate, periphery: periphery normal appearance without retinal tears, breaks, holes, or mass, lens used: 90d, general appearance of the patient is well nourished.Orientation: alert and oriented x 3.Mood and affect: no acute distress.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.A trend related investigation was performed; no trend could be identified.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: AIR OPTIX NIGHT & DAY AQUA
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18108542
• MDR Text Key: 327886222
• Report Number: 9681121-2023-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010043868
• Device Lot Number: 31545931
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: CORRECTION
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Female