MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
The pcb00 20.0 diopter intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).Patient reports os vision worked fine for a week and then went fuzzy: ocular dexter (right eye) has been functioning well.Patient has been able to drive up until recently, last week he decided to sell his car because driving was not safe.When he complained to his doctor, he was told the doctor did not know what was wrong and he was sent to a retina specialist; he has been seeing him for several years.Patient has had two (02) second opinions.The retina specialist sent him to a different doctor, she said she could not help him, saying it was too complicated.She also said the eye was not performing the way she thought it should.Patient is now seeing a new doctor, who also told him he did not want to operate on him.The doctor indicated the price was too high to justify it, but he also stated he had eye pressure issues.He said the pressure is high, and is being monitored frequently.Through follow-up, additional information was received confirming patient has stopped driving due to os visual issues and confirmed no issues with od vision.Os eye pressure issue has been going on for a couple of years but patient does not have a value to provide.No further information is available.
Additional Manufacturer Narrative
Date explanted: not applicable, as the iol remains implanted.The device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt was made to obtain missing information; however, the the patient did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15502700
• Report Number: 3012236936-2022-02417
• Device Sequence Number: 5286074
• Product Code: HQL
• UDI-Device Identifier: 05050474558267
• UDI-Public: (01)05050474558267(17)190402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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: 04/02/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male