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

Lot Number	164739
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec is awaiting additional information about details of the event from the facility.Once the evaluation is complete on the lens, a supplemental report will be issued.Lenstec is unable to corroborate the claim at this time.
Event or Problem Description
An email was received stating "haze on the iol".
Additional Manufacturer Narrative
Lenstec received the device and the results of the evaluation are provided.The lens arrived in three pieces and when put together form a complete lens.Based on the assessment of our batch documentation and the results of the testing conducting, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Lenstec also confirms that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Furthermore, lenstec confirms that there have never been any confirmed lens-related cases of clouding, discolouration or opacification for our hema lenses.
Event or Problem Description
An email was received stating "haze on the iol".

• Brand Name: SOFTEC I
• 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: 7310964
• Report Number: 9613160-2018-00014
• Device Sequence Number: 16458958
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 12/15/2021
• Device Lot Number: 164739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1