MAUDE Adverse Event Report: CIBA VISION GMBH TOTAL 30; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number ASKU

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Scar (1793); Dry Eye(s) (1814); Eye Injury (1845); Intraocular Pressure Increased (1937); Keratitis (1944); Visual Impairment (2138); Eye Pain (4467)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: the complaint sample has not returned for evaluation; the lot number is unknown.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

The consumer had previous irritation and corneal injury, due to which the store advised her to refrain from wearing lenses for the time being, however customer uses the monthly contact lens and subsequently after two or three days of contact lens wearing the complaint of corneal injury resurfaced, and consumer visited emergency room.The physician diagnosed that both eyes are damaged by lenses, the injury had worsened, after wearing contact lenses again for four hours and then consumer took them out as she experienced right eye (od) blurry, which consumer has described she almost see nothing.The physician concluded severe keratitis on od due to contact lenses.Consumer experienced pain behind the eyes.Eye pressure was reported as 30.The complaints have been going on for a month now.The consumer was prescribed with ocular lubricant, hypromellose six times in a day on both eyes (ods) tobramycin/dexamethasone three times a day, ofloxacin ointment three times a day in od.Advice was given not to fly with high eye pressure and to refrain from wearing lenses for at least one week.Consumer was asked to return back after two weeks, physician concluded that contact lens overwear on right eye was more than left eye, consumer has dryness of the conjunctiva on both eyes (sicca), and severe keratitis on od due to soft monthly lenses, now no activity, only thin scars.The customer was asked to discontinue oflaxacin ointment od, and continue with ocular lubricant on both eyes, and hypromellose six times in a day on both eyes.In case of deterioration, red eye, white dot on cornea or further loss of vision returns for further evaluation.Advice not to wear lenses this week, afterwards wear glasses frequently and are advised not to wear monthly lenses but to wear daily lenses for as short a period as possible (for example only during working hours).In the first period, wear lenses for one day and not for one day.At the time of report symptoms are continuing.Additional information has been requested but not yet available.

Event Description

Based on the information received after submitting the initial report, it is confirmed that the consumer experienced only discomfort with the product mentioned in the current report.The events reported in the initial submission (corneal injury, severe keratitis, pain, significant change in visual acuity, keratitis sicca, thin scar, and lens overwear) were not associated with a current complaint, but all were related to other products which has been linked under databased with reference (b)(4).

Manufacturer Narrative

Additional information was provided in b.2, and b.5 based on additional information received following submission of the initial report, this complaint does not meet criteria for the serious adverse event, as it is confirmed that the consumer experienced only discomfort with the product filed under (b)(4) and serious events reported in the initial were not associated with this file id.Please refer filed id (b)(4)for the reported serious adverse events and all future reports will be linked to this file id.The manufacturer internal reference number is: (b)(4).

• Brand Name: TOTAL 30
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer (Section G): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18896886
• MDR Text Key: 337584403
• Report Number: 9610813-2024-00006
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K210436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AQUA BALANCE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female