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

Model Number CQ2015A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  Injury  

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 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.

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.

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
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8957647
• MDR Text Key: 156397336
• Report Number: 2023826-2019-01559
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102049
• UDI-Public: 00841542102049
• Combination Product (y/n): N
• PMA/PMN Number: P990013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 11/04/2019; 11/13/2019
• Supplement Dates FDA Received: 11/04/2019; 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR