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

Model Number ZCU150

Device Problem Difficult to Insert (1316)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that there was a positioning issue with the intraocular lens (iol) being implanted into the patient's operative eye.When the surgeon repositioned the iol, the haptics got caught and tore the anterior capsular bag.There was anterior vitrectomy performed.There was a delay in treatment and no other interventions were performed.There was also vitreous in the anterior chamber.The iol remains implanted.No further information was provided.

Manufacturer Narrative

Age, weight and ethnicity: unknown/not provided.Patient information cannot be provided due to personal data privacy legislation/policy.Explant date: not applicable, as lens remains implanted.(b)(6).Health effect - clinical code 4581: no code available (device dislocation).Device evaluation: product testing could not be performed since the device was not returned for evaluation (lens remains implanted).Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.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: 16640801
• MDR Text Key: 312282632
• Report Number: 3012236936-2023-00743
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474692268
• UDI-Public: (01)05050474692268(17)270819
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2023

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
• Device Operator: Health Professional
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150I175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male