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

Model Number	CC4204A
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Brand name: collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a cc4204a, +20.5 diopter, intraocular lens was implanted into patient's eye on (b)(6) 2019.The lens was removed and replaced for a smaller diopter lens due to "incorrect power calculation" on (b)(6) 2019.This resolved the problem.Per the reporter on (b)(6) 2019, "patient is healing well.".
Additional Manufacturer Narrative
Device evaluation: lens returned in liquid in lens vial in a bio-hazard bag.Visual inspection found optic torn and haptic torn.The lens was returned in three pieces.Device code: 1449 is not applicable; corrected to 2993.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b5- "per the reporter on (b)(6).2019" should be corrected to "per the reporter on 03-dec-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: 9460084
• Report Number: 2023826-2019-02362
• Device Sequence Number: 11523056
• Product Code: HQL
• UDI-Device Identifier: 00841542102407
• UDI-Public: 00841542102407
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• 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: 12/17/2019; 02/26/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/15/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR