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

Catalog Number 000000000010170438

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Corneal Ulcer (1796); Eye Pain (4467)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation; the lot number is n4023837.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

An optician reported that she experienced "intense" pain in the left eye (os) with a pair of trial contact lenses, as well as experiencing a contact lens tearing during wear.She consulted a physician and was diagnosed with a corneal ulcer in the os.At this time of this report, the current status of the eye is not known; additional information has been requested but not yet received.

Event Description

Follow-up information received on 27sep2021 states that the reported event of corneal ulcer occurred after two days of wearing the complaint device.

Manufacturer Narrative

H.3., h.6.: the complaint product has not yet been received at the verification center 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

Follow-up information received on 09oct2021 states that consumer experienced severe rapid onset acute pain and excessive tearing after two days of wear.The consumer was seen by an ophthalmologist and was diagnosed with a corneal ulcer in the left eye (peripheral location, 2mm or less in size).Consumer was prescribed with hexamidine, tobramycin and ciprofloxacin drops.The consumer had also temporarily stopped to wear the contact lenses.At the time of this report symptoms were resolved and consumer plans to resume wearing the contact lenses.

Manufacturer Narrative

A.2, b.5: additional information b.2: based on the additional information received, this event no longer meets reportability requirements, and the previous outcome reported of "other serious" no longer applies.The manufacturer internal reference number is: (b)(4).

• Brand Name: PRECISION1 FOR ASTIGMATISM
• 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: 12518758
• MDR Text Key: 272889487
• Report Number: 9610813-2021-00017
• 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: consumer,foreign,health profe
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

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: 000000000010170438
• Device Lot Number: N4023837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 10/09/2021
• Supplement Dates FDA Received: 10/11/2021; 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR