MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Failure to Eject (4010)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: not applicable, as lens was not implanted.If explanted; give date: not applicable, as lens was not implanted.(b)(6), aphakic.Patient was left aphakic and product was never in contact with patient's eye.New surgery took place on the (b)(6) 2020 and went well.Patient came back for a check up at (b)(6) 2020 and it was all good.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It has been reported issues with pcb00.Cartridge was filled with viscoelastic according to the instruction.When the surgeon was about to push the lens forward, he felt a resistance that was higher than usual.He then pressed a little harder, with the lens leaving the cartridge.Upon inspection, it was seen that one of the lens haptics was partially off/broken.The lens was never inside the patient's eye.Because no backup lens was available, they stopped the surgery and sent the patient home.Rebooked surgery in order for new lenses to arrive at clinic.No sutures were required, no medications were prescribed, patient fully recovered.Patient wellbeing is intact and didn¿t suffer any complications.New surgery took place on the (b)(6) 2020, went good.Patient came back for a check up at (b)(6) 2020 and it was all good.No further information has been provided.
Additional Manufacturer Narrative
Section d10: device available for evaluation? yes.Returned to manufacturer on 1/10/2021.Section h3: device returned to manufacturer? yes.Device evaluation: visual inspection using magnification was performed to the returned sample.The plunger and pushrod was observed in advanced position.The pushrod was observed, that overrides one haptic inside the cartridge.The haptic was observed detached.Residues of lubricant material was observed on cartridge.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The lens was observed, in the loading zone area of the non amo cartridge with on of the haptic folded.The condition in which, the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported, as haptic damaged was not verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed, that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10946971
• Report Number: 2648035-2020-00910
• Device Sequence Number: 3419360
• Product Code: HQL
• UDI-Device Identifier: 05050474557963
• UDI-Public: (01)05050474557963(17)220519
• Combination Product (Y/N): Y
• Initial Reporter Country: SE
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2021
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention