MAUDE Adverse Event Report: MENICON CO., LTD 1MONTH SIHY; LENS, SOFT CONTACT, DAILY WEAR

Lot Number SETL046, SCQL058

Device Problem No Apparent Adverse Event (3189)

Patient Problem Coma (2417)

Event Type  Injury  

Event Description

The patient is in a coma, possibly due to shock or allergic reaction, and is currently hospitalized.It appears that this patient already has some medical history, but the underlying cause of the hospitalization and health impacts has not yet been found.The patient has already undergone several other tests to find the cause.The patient's husband visited a distributor's branch in germany and inquired about the material/chemical composition, as the patient started using "miru 1 month" in march and had some reaction one week later.At this time, we do not have doctor's opinion on the causal relationship with "miru 1 month" because the husband did not provide the branch with the contact information of the hospital or the doctor.We have not been able to obtain detailed information from the doctor (e.G., date of incident, diagnosis, date of hospitalization, etc.).

Manufacturer Narrative

First, additional explanation for the occupation because we couldn't enter text in the part.Third party servicer means an optician of the distributor's branch.The husband of the patient did not tell about the details other than the patient's condition and lens lot number when he visited the distributor's branch in germany.The husband has not yet revisited the branch.The only information we have is a verbal statement from the patient's husband, and as of yet, we have never received any information of the patient or inquiry of lens material/chemical composition directly from the hospital or the attending doctor.We will submit a follow-up report if we obtain additional information.

• Brand Name: 1MONTH SIHY
• Type of Device: LENS, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): MENICON CO., LTD; 21-19, aoi 3,; nagoya, 460-0 006; JA 460-0006
• Manufacturer (Section G): MENICON SEKI PLANT; 3, shinhasama; seki, 501-3 923; JA 501-3923
• Manufacturer Contact: yuki nakakuma ; 21-19, aoi 3, naka-ku; nagoya, 460-0-006 ; JA 460-0006
• MDR Report Key: 15299570
• MDR Text Key: 298667434
• Report Number: 1000188353-2022-00001
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: SETL046, SCQL058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female