MAUDE Adverse Event Report: CIBA VISION JOHOR SDN, BHD. AIR OPTIX FOR ASTIGMATISM; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number CBV92000509

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Abscess (1690); Conjunctivitis (1784); Foreign Body Sensation in Eye (1869); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported on 06mar2019 through the website, the consumer stated that he has been a contact lens user for several years for his myopia and astigmatism.The last ones the consumer purchased are giving him a lot of problems for reason that the contact lenses are thicker.Additional information was received on 20mar 2019, stating that the consumer needed a medical attention and the problem has always been the same.Further information received on 04apr2019 stating the consumer is not experiencing any more discomfort.The consumer added that the reason he sought medical attention was due to a small wound in one of the eye.The treatment took several weeks and the consumer needed two medical intervention.Received additional information on 05apr2019, the consumer was diagnosed of giant papillary conjunctivitis (gpc) od (right eye).Dexamethasone phosphate one drop was prescribed, four times a day for seven days; one drop three times per day for three days; one drop twice per day for three days and one drop once per day for three days.Olopatadine eye drops was given one drop every twelve hours for one month.Sodium cromoglycate eye drops to be given one drop every eight hours for one month.Received a copy of medical record on 15apr2019 which was dated (b)(6) 2018, stating that the consumer experienced ocular discomfort and sought consultation.Personal history was taken and a general impression of ¿ciliary injection temporary lower injury at vii hours para-central with mild sub-epithelial infiltrate in the indicated zone, no perilesional edema and no tyndall¿ was given to the consumer.The diagnosis upon discharge was ¿corneal abscess¿.The consumer was given treatment upon discharge, namely: moxifloxacin eye drops to be given every two hours, tobramycin ophthalmic ointment to be given five times per day, and ketorolac tromethamine eye drops to be given three times a day.The consumer was then discharge on (b)(6) 2018.Another copy of medical record was received the same day of 15apr2019 dated (b)(6) 2018, stating that the primary reason for consultation is due to ocular discomfort.Personal history was also taken and an impression of ¿od conjunctival hyperemia (more in upper quadrant), fluo (-), giant papillae in cts¿ and a diagnosis of giant papillary conjunctivitis was given to the consumer upon discharge.The treatment upon discharge were as follows: dexamethasone eye drop one drop to be given four times per day for seven days, three times per day for three days and in the morning for another three days.Olopatadine eye drops, one drop to be given every twelve hours for one month.Sodium cromoglycate eye drops, one drop to be given every eight hours for one month.The consumer was also instructed to come back for follow-up after one month.The consumer was discharge on the same date of (b)(6) 2018.Additional clarification was received on 03may2019 through telephone.The consumer added that he had a foreign body sensation in his eyes which worsened after the second or third day.The consumer also mentioned that he visited an eye care professional for the third time around (b)(6) 2019, however, no medical report was produced.The ophthalmologist confirmed that the consumer recovered with no sequelae using all the treatment mentioned in the medical report.

Manufacturer Narrative

This is the second of three reports for the same patient involving three lot numbers of the same product.It is unknown which contributed to the event.Refer to 2019-17020-01 for the reported first lot number 31310709.Refer to 2019-17020-03 for the reported third unknown lot number.Device evaluated by mfr: product manufacturing history records were reviewed and the documentation indicated the product met release criteria.The actual complaint product was not returned for evaluation.This lot has passed all the requirements as in accordance of approved procedure and quality sampling inspections prior to release.There is no significant change to the process that relates to the nature of complaint within the period of this manufacturing investigation.All other aspects of causes also has been assessed and found to be in place.No abnormality of internal trending identified during this investigation review.From the dhr finishing review, the lot met the release specification according to manufacturing procedure.The lot has undergone overkill sterilization cycle and the sterilization process parameter and bi incubation result also met specifications.Review on the environmental/utility data, there is no nonconformance reported during the manufacturing of this lot.No contributing factor identified in the manufacturing investigation.Retain sample evaluation was performed and found product was meeting manufacturing specifications as per criteria; visual mantis inspection and vacuum tester for leakage.The results found that there was no sign of leakage observed in the 12 pieces of lenses.Since the complaint samples were not returned for evaluation; there is inability to confirm the product malfunction.The root cause of the complaint could not be determined.The manufacturer internal reference number is: 2019-17020.

• Brand Name: AIR OPTIX FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): CIBA VISION JOHOR SDN, BHD.; #1 dpb/5 tanjung pelepas port; gelang patah; johor darul takzim johor 81560 ; MY 81560
• MDR Report Key: 8585518
• MDR Text Key: 144269327
• Report Number: 3006186389-2019-00007
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K033919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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 Expiration Date: 11/30/2022
• Device Catalogue Number: CBV92000509
• Device Lot Number: 10389508
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/02/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other