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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age: unk.Sex: unk.Weight:unk.Ethnicity: unk.Race: unk.Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: lens was returned in vial, in liquid.Visual inspection found optic and haptic torn.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that on (b)(6) 2019 a cc4204a, +22.0 diopter, intraocular lens tore during loading (before insertion).It was reported that there was no patient contact, no patient injury.Back-up lens was implanted and this resolved the problem.Cause of the event is reported as injector.
Additional Manufacturer Narrative
The reporter indicated that on (b)(6) 2019 a cc4204a, +22.0 diopter, intraocular lens tore during loading (before insertion).It was reported that there was no patient contact, no patient injury.Back-up lens was implanted.Cause of the event is reported as injector.(b)(4).
Additional Manufacturer Narrative
Date of event: corrected to (b)(6) 2019.'device evaluation: the nanopoint injection system was returned in a device tray.Visual inspection of the nanopoint found the plunger bent and no visible damage to the cartridge.' should have been included in initial mdr.Concomitant medical products: injector system model: nanopoint, lot# 181701 should have been included in initial mdr.(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: 9088380
• Report Number: 2023826-2019-01713
• Device Sequence Number: 2819225
• Product Code: HQL
• UDI-Device Identifier: 00841542102438
• UDI-Public: 00841542102438
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2019

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: 04/30/2021
• Device Model Number: CC4204A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 12/11/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/25/2019; 12/11/2019
• 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: INJECTOR SYSTEM MODEL: NANOPOINT, LOT# 181701