MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA PC-60R; INTRAOCULAR LENS

Model Number HOYA PC-60R (+ UNKNOWN D)

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting.Manufacturer's codes for: method, results, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for method, results, and conclusion.

Event Description

Doctor suspect allergy as exfoliation of corneal epithelium appeared after surgery.Patient impact: drug treatment; exfoliation of cornial epithelium.

• Brand Name: HOYA PC-60R
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 9419406
• MDR Text Key: 182397919
• Report Number: 3006723646-2019-00104
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HOYA PC-60R (+ UNKNOWN D)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention