MAUDE Adverse Event Report: CIBA VISION GMBH PRECISION1; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBVUNK00155

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

Patient Problem Ulcer (2274)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

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

As initially reported by a healthcare professional via email on 13nov2020, it was reported that, several female patients developed ulcers.After switching to these contact lenses, a female patent developed second ulcer.Symptoms resolution is unknown.Additional information has been requested.

Manufacturer Narrative

Additional information received; based upon the review of the facts available at this time, this complaint is no longer considered serious or reportable.The manufacturer internal reference number is: (b)(4).

Event Description

On (b)(6) 2020, a female patient complained of pain in the left eye accompanied by significant headache/migraine.She also complaints of pressure feeling and felt photophobic.The eye developed some redness.Upon examination, it was noted that the left cornea was dense inferior, circular ulcer with overlying stain.Anterior chamber are deep with no evidence of cells or flare was noted.Besifloxacin ophthalmic suspension eye drop was prescribed for 48 hours with rtc.On (b)(6) 2020, patient still complained of light sensitive, pressure feeling and headache was present.Eyes are fatigue, tired easily and soreness.Upon examination, corneal inferior marginal ulcer was still quite dense, surrounding edema noted.Patient was diagnosed with marginal corneal ulcer, n/i indicative of sterility of ulcer and likely inflammatory in nature.Patient was also prescribed to add 1% pf at qid closing.(b)(6) 2020, patient had slight improved but still had intense headache/migraine.Upon examination, cornea began to lessen in density and overlying lesion.Deep anterior chamber with no evidence of cells or flare was noted.On (b)(6) 2020, lesion continued to stay defined without edema, margins remained stable, lesion continued to lessen in density.Suspect pain at this juncture is related to headache/migraine and not from the eye.On (b)(6) 2020, patient has improved, examination revealed resolved marginal inferior ulcer resulting in circular scar.Consumer was recommended to resume daily cl wear.

• Brand Name: PRECISION1
• 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: 10903241
• MDR Text Key: 218221975
• Report Number: 9610813-2020-00014
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K182902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBVUNK00155
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR