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 Patient Involvement (2645)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint type events reported for units within the same lot.The lens was returned in liquid, in a lens vial.Visual inspection found that the haptic and optic were torn.(b)(4).
Event or Problem Description
The reporter states that before the surgeon injected a cc4204a intraocular lens, diopter +18.5, he "looked at the lens in the injector and noticed that something looked wrong so he ejected the lens outside the eye and the lens was torn." there was no patient contact with the lens.This occurred on (b)(6) 2019.
Additional Manufacturer Narrative
H6-previous statement-lens work order search: no similar complaint type events reported for units within the same lot.H6-corrected statement-lens work order search: two similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: h3- "delivery system was returned in lens box.Visual inspection found the plunger bent." should be in the initial mdr.Claim# (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 9690225
• Report Number: 2023826-2020-00274
• Device Sequence Number: 19746317
• Product Code: HQL
• UDI-Device Identifier: 00841542102360
• UDI-Public: 00841542102360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2020

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: 10/31/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/14/2020; 01/21/2021
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/03/2020; 02/11/2021
• 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#-UNK
• Patient Age: 74 YR