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	06/21/2019
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
A cc4204a intraocular lens, diopter +24.0 was requested to be returned.Reporter states the lens has a torn haptic and there was no patient contact with the lens.This occurred on (b)(6) 2019.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid, in a lens vial, with clear surgical residue on the product.Visual inspection found the optic torn and a haptic tear.There was also residue on the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
Date received by manufacturer: corrected to 26 jun 2019 in initial mdr.Claim#: (b)(4).
Additional Manufacturer Narrative
The reporter stated that the haptic was torn when stuck in the loader during prep.(b)(4).
Additional Manufacturer Narrative
Lens work order search corrected to: one similar complaint type event reported for units within the same lot.Result code 213 not applicable in 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: 8795446
• Report Number: 2023826-2019-01235
• Device Sequence Number: 19361737
• Product Code: HQL
• UDI-Device Identifier: 00841542102476
• UDI-Public: 00841542102476
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 07/31/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 08/30/2019; 10/01/2019; 10/02/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/21/2019; 09/16/2019; 10/02/2019; 10/03/2019
• 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: INJ MODEL - NANOPOINT, INJ LOT# UNK