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

Model Number	CQ2015A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Lens returned in vial, in liquid.Visual inspection found optic and haptic torn.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 cq2015a, +23.0 diopter, intraocular lens was damaged during insertion into the patient's right eye on (b)(6) 2019.No patient injury was reported.The backup lens was implanted and problem resolved, patient "doing/seeing well." per reporter, anterior vitrectomy performed at the same time.Posterior capsular rent and use of capsular tension ring were observed during surgery.Cause of the event is reported as patient related factor.
Additional Manufacturer Narrative
Adverse event or product problem corrected to adverse event in initial mdr.Outcomes attributed to adverse event corrected to required intervention to prevent permanent impairment/damage in initial mdr.Type of reportable event corrected to serious injury in initial mdr.Patient code 2692 not applicable in initial mdr, device code 3189 not applicable in initial mdr, result code 213 not applicable in initial mdr.
Additional Manufacturer Narrative
Cause of event corrected to unknown in initial mdr.Device code 2682 corrected to device code 2993 in supplemental 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: 8957647
• Report Number: 2023826-2019-01559
• Device Sequence Number: 2609176
• Product Code: HQL
• UDI-Device Identifier: 00841542102049
• UDI-Public: 00841542102049
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2019

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 11/13/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 11/04/2019; 11/13/2019
• 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: 74 YR