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

Model Number	CQ2015A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sex: unk.Ethnicity: unk.Race:unk.Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens 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 a cq2015a, +19.5 diopter, intraocular lens tore during injection into patient's eye on (b)(6) 2019.The lens was implanted, removed, and replaced intraoperatively with no patient injury.This resolved the problem.Per the reporter on 20/nov/2019, "patient is healing well.".
Additional Manufacturer Narrative
H3- device evaluation: lens was returned in a lens vial in liquid.Visual inspection found the optic and haptic torn.The lens was returned in three pieces.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b3- "(b)(6) 2019" should be corrected to "(b)(6) 2019" in the initial mdr.B5- "per the reporter on (b)(6) 2019" should be corrected to "per the reporter on (b)(6) 2019" 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 91016
• MDR Report Key: 9460068
• Report Number: 2023826-2019-02361
• Device Sequence Number: 3078600
• Product Code: HQL
• UDI-Device Identifier: 00841542101974
• UDI-Public: 00841542101974
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2019

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: 09/30/2020
• Device Model Number: CQ2015A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/17/2019; 02/26/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/03/2020; 02/27/2020
• 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: UNK.
• Patient Age: 80 YR