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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens 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, +26.0 diopter, intraocular lens, cracked upon insertion.Lens was removed, another staar lens was implanted, no sutures or wide incision.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Device evaluation: lens was returned in a vial with liquid.Visual inspection found the lens optic and haptic torn.Claim#: (b)(4).
Additional Manufacturer Narrative
Returned to manufacturer: 19/jun/2019 should be corrected to 05/jun/2019 in supplemental medwatch report.Patient code: 2199 should be corrected to 2692 in initial medwatch report.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: 8732181
• Report Number: 2023826-2019-01116
• Device Sequence Number: 2637204
• Product Code: HQL
• UDI-Device Identifier: 00841542102100
• UDI-Public: 00841542102100
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2019

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: 07/31/2019
• 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: 06/05/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/30/2019; 09/09/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/30/2019; 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR