MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated that, after implanting a cc4204a intraocular lens, diopter +19.0 into the patient's eye, the surgeon noticed that the lens was torn.The reporter states that during the loading process the technician felt resistance in the plunger.This occurred on (b)(6) 2018.The lens was removed intraoperatively and an alternate lens was implanted on the same date."no harm to patient" is reported.
Additional Manufacturer Narrative
Date returned to manufacturer: corrected to "02-jan-2019" in the supplemental mdr#1.Claim#: (b)(4).
Additional Manufacturer Narrative
The device was returned in the device tray.The lens was returned inside the cartridge and was smashed between the cartridge wings.Method code added, result code updated.Claim#: (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8254845
• Report Number: 2023826-2019-00089
• Device Sequence Number: 13991932
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: 00841542102377
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/18/2019; 03/25/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/12/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INJECTION SYSTEM MODEL-NANOPOINT, LOT# 158102
• Patient Age: 71 YR