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

Model Number	CC4204A
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	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Device evaluation: the lens was returned in liquid in the lens vial.Visual inspection found the optic was torn.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that, while implanting a cc4204a intraocular lens, diopter +19.0 into the patient's left (os) eye, the lens was damaged.The reporter states the "lens was implanted into patient and retrieved-was damaged.Multiple injectors failed." "no injury to patient" is reported.This occurred on (b)(6) 2018.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Corrected data: the reporter indicated that while implanting a cc4204a intraocular lens of 19.0 diopter into the patient's left eye (os) the lens was damaged.This occurred on (b)(6) 2018.The reporter stated "lens was implanted into patient and retrieved-was damaged." "multiple injectors failed." no patient injury was reported.No back-up iol information was provided and it is unknown whether the patient is pseudophakic.(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: 7906911
• Report Number: 2023826-2018-01441
• Device Sequence Number: 1484960
• Product Code: HQL
• UDI-Device Identifier: 00841542102377
• UDI-Public: 00841542102377
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2018

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: 02/29/2020
• Device Model Number: CC4204A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: 50 YR