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

Model Number	Z9002
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation: product evaluation was not performed because the product has not been returned.If product is received after initial closure, the ir and complaint file (if necessary) may be re-opened to complete the return investigation.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was inserted into patient's eye and tear was noticed on the lens.The surgeon removed the lens and implanted another.It was stated that there were no adverse reactions to report.No other information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review it was determined that section h6: medical device problem code was inadvertently indicated in the initial mdr submitted as haptic detached when it should be iol torn.Section below updated in this report.H6: medical device problem code: 4008.Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: 2/25/2021 section h3.Device evaluated by manufacturer? yes device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during removal and replacement.Furthermore, the optic body of the lens was observed to be torn in half (but not separated).Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue was confirmed, however this can be attributed to handling and cannot be confirmed to be related to manufacturing and no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11213351
• Report Number: 2648035-2021-07119
• Device Sequence Number: 3360366
• Product Code: HQL
• UDI-Device Identifier: 05050474530737
• UDI-Public: (01)05050474530737(17)250529
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2025
• Device Model Number: Z9002
• Device Catalogue Number: Z900200220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE, MODEL AND LOT# UNKNOWN