MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H-10; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.The lens was returned in liquid in case/vial.Visual inspection found the lens optic and one haptic torn off and missing.No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a cq2015a collamer three piece lens, +22.0 diopter, and the haptic was noted to be torn.The lens was removed with no patient injury, no incision enlargement or sutures.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Adverse event or product problem corrected to adverse event in initial mdr.Outcomes attributed to adverse event corrected to other serious in initial mdr.Event discription should have included: "the reporter did not indicate whether a back-up iol was implanted after the initial iol was removed.Thus, the patient is considered aphakic.Leaving a patient with aphakia after the removal of the patient's natural crystalline lens is considered an injury." type of reportable event corrected to serious injury in initial mdr.Patient code 2199 corrected to patient code 3191 (no code available: aphakia).2199 is not applicable in initial mdr.Device code 3189 corrected to device code 2993.3189 is not applicable in initial mdr.Claim#: (b)(4).

• Brand Name: SEE H-10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8834093
• Report Number: 2023826-2019-01309
• Device Sequence Number: 19592804
• Product Code: HQL
• UDI-Device Identifier: 00841542102025
• UDI-Public: 00841542102025
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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: CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Outcome Attributed to Adverse Event: Other