MAUDE Adverse Event Report: CIBA VISION GMBH DAILIES TOTAL 1; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92004051

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

Patient Problems Corneal Ulcer (1796); Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was initially reported on (b)(6) 2018 that a consumer developed a sub-conjunctival hemorrhage on her left eye on (b)(6) 2018.It was reported that the left contact lens was "bothering" to the consumer.It was reported that redness on the temporal part of the sclera was observed with absence of pain.It was reported that the consumer experienced a ¿very painful¿ left eye upon waking up on (b)(6) 2018 and it was also noted that the eye redness was more diffused.The eye care professional (ecp) diagnosed the consumer with corneal ulcer.The consumer was prescribed with besifloxacin ophthalmic suspension (0.6%), one drop four times a day (qid); preservative-free lubricant eye drops, one drop every hour while awake; and tobramycin and dexamethasone ophthalmic solution with an unspecified treatment modality.Additional treatment with a cryopreserved amniotic membrane insertion was made on (b)(6) 2018.Consumer was advised to stop wearing contact lenses until (b)(6) 2018.Consumer was scheduled for a follow-up appointment and removal of the membrane on (b)(6) 2018.Additional information was received on (b)(6) 2018 via email stating that the corneal ulcer on the left eye has completely healed and that the tobramycin and dexamethasone ophthalmic solution will be discontinued by (b)(6) 2018.The consumer was advised to refrain from contact lens wear until (b)(6) 2018.Additional information has been requested but not yet received.

Manufacturer Narrative

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).

Event Description

Additional information via email was received on 15may2018, stating that the consumer has resumed contact lens wear and the consumers vision was back to normal.It was also reported that there was a small scar on the os but it does not affect the consumers visual acuity.

• Brand Name: DAILIES TOTAL 1
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION GMBH; postfach, industriering 1; grosswallstadt D-638 68; GM D-63868
• MDR Report Key: 7446137
• MDR Text Key: 106010866
• Report Number: 9610813-2018-00005
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K113168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CBV92004051
• Device Lot Number: N1151789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other