MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS ITEC PRELOADED IOL; TECNIS IOL

Model Number PCB00

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.Explant date: not applicable as the device remains implanted.Telephone number: (b)(6).Device evaluation: a returned device evaluation could not be performed as the device remains implanted.Manufacturing record review: the manufacturing records review for this product order (po) shows that the units were released within specification.No non-conformance (nc) or exception report (er) was found as part of the manufacturing records review.A search of complaints related to this production order was performed on (b)(6) 2022.The search revealed that no other complaints were received for this po.Conclusion: based on the investigation results, no non-conformity report, documentation or labeling changes, or escalations are required.The complaint issue reported could not be verified and no product deficiency could be identified.Johnson & johnson surgical vision will continue to monitor these types of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the patient was implanted with 22d preloaded aspheric one-piece acrylic intraocular lens.The lens came out earlier than expected at 15:20 and was re-implanted / repositioned in the patient's eye at 15:23.The lens was fully inserted and remains implanted.The patient was satisfied post-operatively.No further information was provided.

• Brand Name: TECNIS ITEC PRELOADED IOL
• Type of Device: TECNIS IOL
• 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: 16057765
• MDR Text Key: 308378170
• Report Number: 3012236936-2022-03199
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCB00
• Device Catalogue Number: PCB000C220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2022
• 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 Age: 84 YR
• Patient Sex: Female