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

Model Number	CC4204A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Corneal Edema (1791); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a cc4204a, +19.5 diopter, intraocular lens from patient's eye on (b)(6) 2019.Surgeon "felt" the lens did not fit in the eye.There was no patient injury.The lens implanted, removed, and replaced intraoperatively.This resolved the problem.Reportedly the lens was "replaced with another staar lens." per reporter on (b)(6) 2019, "patient is healing with corneal edema.".
Additional Manufacturer Narrative
Corrected data: b5 - see mfr# 2023826-2020-00025 for replacement lens claim regarding patient's corneal edema.H6 - patient code: 1791 should be corrected to 2692.Additional information: h6 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 - lens was implanted and removed intraoperatively.It is unclear if replacement lens occurred intraoperatively at time of initial lens removal or at another date.Claim#: (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: lens was returned in a vial in liquid.Visual inspection found the lens optic and haptic torn and the lens was returned in four pieces.Corrected data: h6 - result code: 213 should have been included in supplemental medwatch report #1.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: 9460055
• Report Number: 2023826-2019-02359
• Device Sequence Number: 16913537
• Product Code: HQL
• UDI-Device Identifier: 00841542102384
• UDI-Public: 00841542102384
• 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,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: CC4204A
• 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: 01/02/2020; 12/17/2019; 01/22/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/02/2020; 01/03/2020; 01/22/2020
• 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: 79 YR