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

Model Number ZA9003

Device Problem Scratched Material (3020)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of event is unknown, not provided, but it was indicated that the scratched lens issue was not noticed at the time of implant and reportedly, after the first postop visit; however, the best estimate date is between (b)(6) 2021 and (b)(6) 2021.Initial reporter telephone extention: (b)(6) the intraocular lens (iol) has not returned for evaluation; 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was explanted from the patient's right eye in a secondary surgical procedure due to noted striae, scratches on the posterior side/optic superior portion of the lens.The scratched lens issue was not noticed at the time of implant and reportedly, after the first post-op visit.It was indicated that the symptoms persisted since the primary surgery.The patient was prescribed ca3 medication (cataractive 3 eye drops).The incision was enlarged and sutures were used.A different lens model (za9002), but same diopter was used as the replacement iol.No other surgical interventions were required.It was confirmed that the patient has fully recovered.No further information is available.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: jan 13, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside the replacement lens case.The replacement lens¿s folding carton was also received along with the direction for used (dfu) and patient stickers.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half as well as both haptics being detached.The lens was cleaned, and no cosmetic defects, including scratches, were found.The complaint issue could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: 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: 13120872
• MDR Text Key: 285678661
• Report Number: 3012236936-2021-00378
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474529038
• UDI-Public: (01)05050474529038(17)260516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMERALDC30 CARTRIDGE, LOT# CJ17537
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Race: White