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

Model Number	CC4204A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Clouding, Central Corneal (2228); No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted a cc4204a collamer single piece lens, +21.5 diopter, and the lens tore.The lens was removed with no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
B5: the reporter indicated the incision was enlarged to remove the lens during the same surgery, there were no sutures.A three-piece lens was implanted as the replacement lens.The patient's iris was damaged when the lens was being removed and patient has corneal clouding.The patient will be going to another doctor for corneal repair.No more information was available.H6 - device code: 3191 - incision enlarged; iris damage.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: b5: the lens was torn when pushed out of the injector.There was a large tear the entire central lens.The lens was replaced with another lens.There was no vitreous loss or patient injury.H3: device evaluation: the lens was returned in liquid in lens vial.Visual inspection found the lens optic and haptics torn.The lens was returned in two pieces.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: 9528025
• Report Number: 2023826-2019-02498
• Device Sequence Number: 13552815
• Product Code: HQL
• UDI-Device Identifier: 00841542102421
• UDI-Public: 00841542102421
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2019

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: 01/31/2021
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/03/2020; 01/29/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 01/22/2020; 02/19/2020
• 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