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

Model Number ZA9003

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Patient age and date of birth, patient weight, and ethnicity and race: unknown as information was asked, but not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted; therefore, not explanted.Device evaluation: the product testing could not be performed as the product was not returned for evaluation (the device was discarded).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the za9003 intraocular lens (iol) was defective and extent of patient contact is unknown.Iol is not available for return as it was discarded.No further information is available.

• 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: 16066109
• MDR Text Key: 306624519
• Report Number: 3012236936-2022-03180
• Device Sequence Number: 1
• Product Code: HQL
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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