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

Lot Number	174322
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens and additional information not yet returned to manufacturer.However, preliminary results revealed no discrepancies found as it relates to the batch documentation analysis.The audit determined that all procedures in the manufacturing and packaging of the lens had been carried out correctly.Batch reconciliation was 100%.Once additional information is received a supplemental report will be submit.
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens did not unload correctly and was removed from patient eye.Another lens type and size was loaded and implanted to patient.No adverse event occured".
Additional Manufacturer Narrative
Lens returned to manufacturer.Results revealed no discrepancies found as it relates to the batch documentation analysis.A deep scratch was noted across the optic, due to removal.No other defects were noted the audit determined that all procedures in the manufacturing and packaging of the lens had been carried out correctly.Batch reconciliation was 100%.Without the availability of the instruments used lenstec is unable to comment on the suitability and refers the user to the instructions for proper use.
Event or Problem Description
Lenstec, inc.Received an email notification stating "lens did not unload correctly and was removed from patient eye.Another lens type and size was loaded and implanted to patient.No adverse event occured".

• Brand Name: SOFTEC HDO
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92,; BB BB17092,
• MDR Report Key: 8144009
• Report Number: 9613160-2018-00038
• Device Sequence Number: 13503820
• Product Code: HQL
• UDI-Device Identifier: 00844369037464
• UDI-Public: 00844369037464
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/04/2019

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: 12/20/2022
• Device Lot Number: 174322
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1