MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS

Lot Number	190405
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.Due to the absence of the lens, lenstec was unable to perform a more thorough investigation of the complaint.A supplemental report will be completed once a lens investigation can be completed.
Event or Problem Description
Lenstec received an email stating that "trailing haptic got cut off during insertion and had contact with patient".
Event or Problem Description
Lenstec received an email stating that "trailing haptic got cut off during insertion and had contact with patient".This is the supplemental report.
Additional Manufacturer Narrative
This is the supplemental report after the lens was returned to our facility.The visual examination revealed that the haptic tore as a result of being handled whilst in a dehydrated state during the implantation.Furthermore, lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.Attachment: [(b)(4) - final report.Pdf].

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 9384835
• Report Number: 9613160-2019-00032
• Device Sequence Number: 2402717
• Product Code: HQL
• UDI-Device Identifier: 00844369029506
• UDI-Public: 00844369029506
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2024
• Device Lot Number: 190405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1