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

Lot Number	131557
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly and that the quality of the lens is not at fault.The investigation revealed that the jagged break on one haptic appeared to be a tear, while me smooth break on the other haptic is most likely a snap; lenstec is unable to determine a specific cause for this damage.Lenstec however advises the user to consult the instructions for use (ifu) supplied with the lens which illustrates the correct method for loading and injecting the lens.Furthermore, we are unable to comment on the suitability of the instruments used by the surgeon with the lens as this information was not provided.
Event or Problem Description
Lenstec received an email stating that "inserted into eye.Noted haptic was broke completely off.Removed.Inserted another hdo lens.No patient injury or surgical intervention required.".

• Brand Name: SOFTEC HDO
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 8524411
• Report Number: 9613160-2019-00013
• Device Sequence Number: 14170408
• Product Code: HQL
• UDI-Device Identifier: 00844369037402
• UDI-Public: 00844369037402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 06/02/2018
• Device Lot Number: 131557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2013
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1