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

Catalog Number CBV92092165

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ulcer (2274); Discomfort (2330)

Event Date 02/03/2021

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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a physician via personal communication on (b)(6) 2021, it was stated that on an unspecified date, consumer experienced discomfort after wearing the lens for 2 - 3 days of use, the consumer visited the physician and was diagnosed with ulcer.Symptoms were continuing.Additional info has been requested but not yet available.

Event Description

Additional information received on 18feb2021, from the doctor via sales representative.On 03feb2021, the consumer experienced irritation not discomfort; approx.After 2 days of lens use.The consumer visited a doctor (b)(6) 2021 and was diagnosed with corneal ulcer.Ulcer occurred in the consumer¿s right eye.The ulcer reaches the pupil when the pupil dilates; located at 3:4o'clock direction of the eye.Eye drops: (hydroxypropyl methylcellulose/ moisture agent, gatifloxacin/ antibacterial, pranoprofen / non-steroidal anti inflammation) were prescribed.In addition, (diquafosol sodium / moisture agent, ofloxacin ointment / type unknown) were prescribed later on.On (b)(6) 2021, corneal ulcer and subjective symptom had resolved.Although the corneal cell is still cloudy, the doctor concluded that no further medical treatment is necessary.Symptom has been resolved.Additional info has been requested but not yet available.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

H.3., h.6.: the lot number was not provided and the complaint sample was not made available for evaluation.No complaint or manufacturing trend was identified.The root cause could not be determined.Correction g.3: supplemental medical device report (smdr) # 2 is being filed to correct the g.3 date on the supplemental report, filed earlier.Incorrect date of 18/02/2021 is being corrected to 16/02/2021.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The complaint product was returned for evaluation and was found to meet manufacturing specifications.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.

Event Description

Additional information received on (b)(6) 2021, lot number has been retrieved at the verification site, which was (b)(4).

Event Description

Additional information was received for this event.The consumer sought medical treatment from a doctor, it was indicated that the consumer experienced irritation approximately after 2 days of lens use.The consumer was diagnosed corneal ulcer in right eye ¿reaching the pupil when the pupil dilates, located at 3:4o'clock direction of the eye.¿ the consumer received antibacterial, non-steroidal, anti-inflammation eye drops and doctor concluded that no further medical treatment required and to resume contact lens wear.The doctor cannot determine whether the ulcer was caused by the contact lens.

Manufacturer Narrative

The reported event does not meet criteria as a serious adverse event based on information provided by the consumer and healthcare provider.The manufacturer internal reference number is: (b)(4).

• 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: 11320991
• MDR Text Key: 231616815
• Report Number: 9610813-2021-00004
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CBV92092165
• Device Lot Number: N4008312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2021
• Initial Date Manufacturer Received: 02/07/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/17/2021; 03/02/2021; 05/21/2021; 08/13/2021
• Supplement Dates FDA Received: 02/24/2021; 03/16/2021; 05/25/2021; 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other