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

Catalog Number 000000000010164659

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Excessive Tear Production (2235); Eye Burn (2523)

Event Date 10/06/2023

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.D.4: this is the first of two reports for the same consumer involving two different lot numbers of the same product which contributed to the event.Refer to the second report filed under the manufacturer internal reference number of (b)(4).The manufacturer internal reference number is: (b)(4).

Event Description

An initially reported by physician stating that consumer experienced burning, discharge and redness in the eyes after wearing the contact lenses.The consumer was diagnosed with marginal ulcers bilateral and treated with unspecified medication.The product was discontinued, and the consumer was switched to another brand.Additional follow up received with medical records from physician stating that the consumer sought hospital visit with the chief complaint of redness in left eye (os) is more than right eye (od), scratchy in the os.Additionally, consumer stated rinsed eyes with saline as recommended by primary care physician and symptoms were improved slightly.On the day of visit symptoms were worse, physician said might the consumer had taken a nap while wearing contact lenses.Biomicroscope tests on cornea confirmed epithelial ulceration marginal on both eyes (ou).The consumer was treated with moxifloxacin hcl 0.5 percent one drop on ou for every two hours for two days following four times a day on next day for ou.The consumer was advised to visit for next follow up.The current condition of the consumer¿s eye is symptoms resolved.Additional info has been requested but not yet received.

Manufacturer Narrative

H.3., h.6.: the actual complaint product was not returned for evaluation.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: 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: 18756500
• MDR Text Key: 335934881
• Report Number: 9610813-2024-00004
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000000000010164659
• Device Lot Number: N4108467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TOTAL 30.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Male