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

Model Number HOYA PY-60AD (+24.50 D)

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting.The manufacturer's codes for: method; results; and, conclusion - are pending completion of the manufacturer's product/complaint investigation - which will be conducted after the return product is received.Once the 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

Patient, male, (b)(6), treated with cataract of left eye in hospital.After detailed examination, at 9:00 on (b)(6) 2019, the operation of phacoemulsification and iol implantation was implemented by doctor.But while pre-loading iol, its haptic was deformed, it was replaced by a new iol immediately.There was no any adverse impact to patient, patient's vision recovered well after surgery.Event occurred in (b)(6), there was no impact to patient, but it was reported by hospital as ae to (b)(6) authority.

Manufacturer Narrative

This follow-up #1 emdr is being submitted to fda for outside us like products reporting.Corrections and additional information which were not available/included in the initial report are noted below: section d10 - device available for evaluation - indicated yes, and added the product returned date.Section g7- indicated follow-up #1.Section h2 - type of follow up report - indicated "correction" and "additional information".Section h3 - device evaluated? - corrected to yes.Section h6 - manufacturer's codes for: method; results; and, conclusion - have been added based on the results of the manufacturer's product investigation.Product investigation results are noted below: the lens was ejected out from the injector.One haptic was deformed at middle part and detached from the optic.The edge of the optic near the other haptic was chipped off.The injector was not returned.Review of the production records showed no nonconformities and/or deviations from the specifications.The batch was manufactured following established and validated procedure and no deviation or non-conformities were reported in these cases.From available information and the condition of returned product, we couldn't determine which haptic was deformed during insertion, and we also couldn't ascertain exact cause of deformed haptic from the returned lens.Risk assessment: a review of the most recent complaint trending data indicates that no significant trends have been identified at this time, and no capa is required as part of the product evaluation.

Event Description

Patient, male, 47 years, treated with cataract of left eye in hospital.After detailed examination, at 9:00 on (b)(6), 2019, the operation of phacoemulsification and iol implantation was implemented by doctor.But while pre-loading iol, its haptic was deformed, it was replaced by a new iol immediately.There was no any adverse impact to patient, patient's vision recovered well after surgery.Event occurred in china, there was no impact to patient, but it was reported by hospital as ae to chinese authority.

• Brand Name: HOYA PY-60AD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 8724982
• MDR Text Key: 191897250
• Report Number: 3006723646-2019-00086
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: HOYA PY-60AD (+24.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other