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

Model Number CC4204A +16.5

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2020

Event Type  Injury  

Manufacturer Narrative

Collamer ultraviolet-absorbing posterior chamber single piece foldable intraocular lens.Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated that a cc4204a, +16.5 diopter, intraocular lens was inserted into the patients eye and the doctor felt it was too tight.The lens was removed and replaced with a different lens, no patient complication noted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

H3- device evaluation : lens was returned in liquid, inside vial.Lens was returned in pieces, unable to evaluate.(b)(4).

Manufacturer Narrative

Claim#: (b)(4).

• Brand Name: SEE H10
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10338047
• MDR Text Key: 200817319
• Report Number: 2023826-2020-01602
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00841542102322
• UDI-Public: 00841542102322
• 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: 06/30/2020

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 Model Number: CC4204A +16.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 12/29/2020
• Supplement Dates FDA Received: 09/19/2020; 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR